N/A 305106Recalls & reported problems

Summary

The FDA's MAUDE database contains 467 adverse event reports that list this exact device (DI 00382903051069), received between Nov 6, 2017 and Sep 8, 2026 — classified as 8 injuries, 459 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (247 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K021475); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 18, 2020Terminated

   BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.

   Z-0588-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 467 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676793 ↗
• MalfunctionSep 8, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676792 ↗
• MalfunctionApr 6, 2026Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE NEEDLE 30X1/2 RB, LEAKAGE OCCURRED, RESULTING IN MEDICATION IN DOCTOR'S EYES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHEN MEDICATION WAS PUSHED (LIDOCAINE) THE MEDICATION CAME OUT FROM THE HUB AND LUER LOCK CONNECTOR RESULTING IN MEDICATION GETTING IN THE DOCTOR'S EYES. THIS OCCURRED IN THE ER SETTING. SOME NEEDLES SEEM TO BE CLOGGED RESULTING IN NOT DRAWLING UP MEDICATION. ADDITIONAL INFORMATION: THE DOCTOR HAS TO FLUSH HIS EYES.

  Patient problems: Fluid Discharge

  MAUDE report 24789727 ↗
• InjuryApr 2, 2026Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE NEEDLE 30 X 1/2 RB, LEAKAGE OCCURRED, RESULTING IN MEDICATION IN DOCTOR'S EYES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHEN MEDICATION WAS PUSHED (LIDOCAINE) THE MEDICATION CAME OUT FROM THE HUB AND LUER LOCK CONNECTOR RESULTING IN MEDICATION GETTING IN THE DOCTOR'S EYES. THIS OCCURRED IN THE ER SETTING. SOME NEEDLES SEEM TO BE CLOGGED RESULTING IN NOT DRAWLING UP MEDICATION. ADDITIONAL INFORMATION: THE DOCTOR HAS TO FLUSH HIS EYES.

  Patient problems: Fluid Discharge

  MAUDE report 24769427 ↗
• MalfunctionApr 1, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755768 ↗
• MalfunctionMar 16, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. DESCRIPTION: BLACK SPECS WERE OBSERVED UNDER THE NEEDLE CAP, LEADING THE HEALTHCARE PROVIDER TO BELIEVE THAT THE NEEDLE WAS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604942 ↗
• MalfunctionMar 13, 2026Crack; Leak/Splash

  IT IS REPORTED A CRACK ON THE NEEDLE HUB, CAUSING LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597970 ↗
• MalfunctionFeb 27, 2026Contamination

  DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469931 ↗
• MalfunctionJan 20, 2026Loose or Intermittent Connection

  IT IS REPORTED CONNECTION ISSUES. VERBATIM: MATERIAL 305106 BATCH 4081033 ON 08SEP2025 REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI INSECURE NEEDLE-SYRINGE CONNECTION ON 08SEP2025, THE OFFICE STAFF REPORTED THE FOLLOWING: THERE WAS A FAULTY SYRINGE FOR THE DOCTOR. WHEN HE WAS TRYING, IT WASN'T CLICKING AND IT WAS LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 24118113 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305106 BATCH # 3347539. IT WAS REPORTED BY CUSTOMER THAT PATIENT DEVELOPED POST-INJECTION ENDOPHTHALMITIS FOLLOWING INTRAVITREAL INJECTION USING BD PRECISIONGLIDE NEEDLE. RCC RECEIVED A COMPLAINT VIA EMAIL. POST-PROCEDURE INFECTION: ENDOPHTHALMITIS. PATIENT WITH KNOWN CENTRAL RETINAL VEIN OCCLUSION (CRVO) AND MACULAR EDEMA ON CHRONIC INTRAVITREAL EYLEA INJECTION THERAPY DEVELOPED POST-INJECTION. ENDOPHTHALMITIS IN THE RIGHT EYE. PATIENT RECEIVED USUAL INTRAVITREAL INJECTION OF EYLEA 2MG OD ON (B)(6) 2025. INJECTION PROCEDURE WAS WITHOUT COMPLICATION. THE FOLLOWING DAY DEVELOPED PAIN AND DECREASED. VISION PROMPTING A VISIT TO THE MERCY ED. ON EXAMINATION SHE WAS NOTED TO HAVE SIGNIFICANT INTRAOCULAR. INFLAMMATION AND MARKEDLY REDUCED VISION CONCERNING FOR ACUTE ENDOPHTHALMITIS. SHE WAS TAKEN. URGENTLY TO THE OPERATING ROOM ON (B)(6) FOR VITRECTOMY/VITREOUS BIOPSY (BX) + INTRAVITREAL INJECTION. OF ABX(ANTIBIOTICS). CULTURES GREW STREPTOCOCCUS MITIS GROUP. ENDOPHTHALMITIS REPRESENTS A RARE BUT SERIOUS COMPLICATION OF INTRAVITREAL INJECTION WITH POTENTIAL FOR SIGNIFICANT VISUAL MORBIDITY. MODEL #: 305106 LOT #:

  Patient problems: Endophthalmitis

  MAUDE report 23772196 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB NEEDLE HUB WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305106 BATCH #4116510, 5091104, 4159365, 4116511, 4116509. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT REF 305106 LOT 4116510, 5091104, 4159305, 4116511 ISSUE: CAN DRAW IN SOLUTION AND ATTEMPTING TO EXPEL AIR, THE NEEDLE IS BLOCKED. THERE APPEARS TO BE PARTICLES COMING OFF THE NEEDLE HUB SUSPECT THAT THEY MAYBE BLOCKING THE NEEDLE. DOE 22OCT2025 UNKNOWN LOT POSSIBLY OTHER WILL PROVIDE WHEN ACKNOWLEDGEMENT IS SENT. SAMPLES: ONE SAMPLE-UNCONTAMINATED REPRESENTATIVE SAMPLES -(B)(4). ADDITIONAL INFORMATION PROVIDED: IT IS BEING REPORTED AS HUBS BREAKING APART OUTPATIENT NEUROLOGY IN MURFREESBORO IS HAVING AN INTERMITTENT ISSUE WITH THE HUBS BREAKING APART WITH THE FOLLOWING NEEDLE- WRAPPER INFORMATION IS PROVIDED AS WELL ON THE PHOTOS WITH LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622103 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB NEEDLE HUB WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305106. BATCH #4116510, 5091104, 4159365, 4116511, 4116509. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT: REF 305106 LOT 4116510, 5091104, 4159305, 4116511 ISSUE: CAN DRAW IN SOLUTION AND ATTEMPTING TO EXPEL AIR, THE NEEDLE IS BLOCKED. THERE APPEARS TO BE PARTICLES COMING OFF THE NEEDLE HUB SUSPECT THAT THEY MAYBE BLOCKING THE NEEDLE. (B)(6) 2025 UNKNOWN LOT POSSIBLY OTHER WILL PROVIDE WHEN ACKNOWLEDGEMENT IS SENT. SAMPLES: (B)(4) SAMPLE-UNCONTAMINATED. REPRESENTATIVE SAMPLES - (B)(4). ADDITIONAL INFORMATION PROVIDED: IT IS BEING REPORTED AS HUBS BREAKING APART. OUTPATIENT NEUROLOGY IN (B)(6) IS HAVING AN INTERMITTANT ISSUE WITH THE HUBS BREAKING APART WITH THE FOLLOWING NEEDLE- WRAPPER INFORMATION IS PROVIDED AS WELL ON THE PHOTOS WITH LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622101 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB NEEDLE HUB WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305106, BATCH#: 4116510, 5091104, 4159365, 4116511, 4116509. RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCT COMPLAINT: REF: (B)(4), LOT: 4116510, 5091104, 4159305, 4116511. ISSUE: CAN DRAW IN SOLUTION AND ATTEMPTING TO EXPEL AIR, THE NEEDLE IS BLOCKED. THERE APPEARS TO BE PARTICLES COMING OFF THE NEEDLE HUB SUSPECT THAT THEY MAYBE BLOCKING THE NEEDLE. DOE: ON (B)(6) 2025, UNKNOWN LOT POSSIBLY OTHER WILL PROVIDE WHEN ACKNOWLEDGEMENT IS SENT. SAMPLES: ONE SAMPLE-UNCONTAMINATED. REPRESENTATIVE SAMPLES -20. ADDITIONAL INFORMATION PROVIDED: IT IS BEING REPORTED AS HUBS BREAKING APART OUTPATIENT NEUROLOGY IN MURFREESBORO IS HAVING AN INTERMITTENT ISSUE WITH THE HUBS BREAKING APART WITH THE FOLLOWING NEEDLE- WRAPPER INFORMATION IS PROVIDED AS WELL ON THE PHOTOS WITH LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622100 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB NEEDLE HUB WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305106, BATCH#: 4116510, 5091104, 4159365, 4116511, 4116509. RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCT COMPLAINT: REF: (B)(4), LOT: 4116510, 5091104, 4159305, 4116511. ISSUE: CAN DRAW IN SOLUTION AND ATTEMPTING TO EXPEL AIR, THE NEEDLE IS BLOCKED. THERE APPEARS TO BE PARTICLES COMING OFF THE NEEDLE HUB SUSPECT THAT THEY MAYBE BLOCKING THE NEEDLE. DOE ON (B)(6) 2025, UNKNOWN LOT POSSIBLY OTHER WILL PROVIDE WHEN ACKNOWLEDGEMENT IS SENT. SAMPLES: ONE SAMPLE-UNCONTAMINATED. REPRESENTATIVE SAMPLES -20. ADDITIONAL INFORMATION PROVIDED: IT IS BEING REPORTED AS HUBS BREAKING APART OUTPATIENT NEUROLOGY IN MURFREESBORO IS HAVING AN INTERMITTENT ISSUE WITH THE HUBS BREAKING APART WITH THE FOLLOWING NEEDLE- WRAPPER INFORMATION IS PROVIDED AS WELL ON THE PHOTOS WITH LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621941 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB NEEDLE HUB WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305106 BATCH #4116510, 5091104, 4159365, 4116511, 4116509 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCTCOMPLAINT REF 305106 LOT 4116510, 5091104, 4159305, 4116511 ISSUES: CAN DRAW IN SOLUTION AND ATTEMPTING TO EXPEL AIR, THE NEEDLE IS BLOCKED. THERE APPEARS TO BE PARTICLES COMING OFF THE NEEDLE HUB SUSPECT THAT THEY MAYBE BLOCKING THE NEEDLE. DOE (B)(6) 2025 UNKNOWN LOT POSSIBLY OTHER WILL PROVIDE WHEN ACKNOWLEDGEMENT IS SENT. SAMPLES: ONE SAMPLE-UNCONTAMINATED REPRESENTATIVE SAMPLES -20 ADDITIONAL INFORMATION PROVIDED: IT IS BEING REPORTED AS HUBS BREAKING APART OUTPATIENT NEUROLOGY IN MURFREESBORO IS HAVING AN INTERMITTANT ISSUE WITH THE HUBS BREAKING APART WITH THE FOLLOWING NEEDLE- WRAPPER INFORMATION IS PROVIDED AS WELL ON THE PHOTOS WITH LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621939 ↗
• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. MATERIAL: 305106, BATCH#: 4081033. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER: (B)(4). COMPLAINT DESCRIPTION: ON 30JUL2025 XX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE ¿ DEFECTIVE SYRINGE . ON 28JUL2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿WHEN THE DOCTOR ATTEMPTED TO REMOVE THE INJECTION NEEDLE CAP, IT AUTOMATICALLY STARTED "SHOOTING OUT (THE MEDICATION)" WITHOUT PRESSING THE PLUNGER.¿ LOT: 8463800035 INJECTION NEEDLE, CATALOG: 305106, LOT: 4081033. INVESTIGATIONAL REQUEST /RETURN COMPONENT STATUS PLEASE PERFORM AN EVALUATION OF THE PROCESS AND SAMPLE TO DETERMINE ANY POTENTIAL CONTRIBUTING FACTORS TO THE NEEDLE BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596423 ↗
• MalfunctionAug 18, 2025Break; Break

  IT IS REPORTED BROKEN NEEDLE. EVENT DESCRIPTION: MATERIAL # 305106, BATCH # 3334821. ON (B)(6) 2025 REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI - BROKEN FILTER NEEDLE. THE OFFICE STAFF REPORTED THE FOLLOWING: ¿THE NEEDLE BROKE OFF THE SYRINGE WHEN THE PHYSICIAN WAS ATTEMPTING TO SWITCH NEEDLES WHILE PREPARING AN EYLEA HD DOSE ON (B)(6) 2025. SHE EXPLAINED THE PLASTIC PART AT THE BASE OF THE SYRINGE WHERE THE NEEDLE ATTACHES BROKE OFF WHEN THE PHYSICIAN WENT TO ¿TWIST OR PULL¿ THE FILTER NEEDLE OFF.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827862 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED ENDOPHTHALMITIS. EVENT DESCRIPTION: MATERIAL # 305106. BATCH # 4060059, 4031552. MY NAME IS (B)(6), I'M A RETINAL TECHNICIAN, AND I'M SENDING THIS MESSAGE ON BEHALF OF (B)(6) AND IN REGARD TO THE 30G X 1/2 (0.3MM X 13MM) NEEDLES (REF - (B)(4)). OVER THE PAST MONTH WE'VE SEEN AN INCREASE IN OUR ENDOPHTHALMITIS RATE (THIS HAS BEEN IRRESPECTIVE OF CLINICIAN OR DRUG BEING GIVEN). SINCE THIS WAVE OF INFECTIONS, WE HAVE CHANGED ALL THE VARIABLES ON OUR END THAT WERE ABLE TO (I.E. THE MANNER IN WHICH WE NUMB PATIENTS, DISCARDING NUMBING DROPS, ETC). THE ONLY COMMON DENOMINATOR AMONGST ALL OF THESE INSTANCES IS THE BRAND OF AND LOT #S OF THE NEEDLES THAT HAS BEEN USED (LOT S 4060059 AND 4031552). WE'VE BEEN MONITORING THE (B)(6) WEBSITE AS WELL THE BD WEBSITE OF ALL RECALLS AND WE HAVEN'T SEEN ANY RECENT RECALLS WITH THESE SPECIFIC LOTS (4060059 AND 4031552). WE'RE INQUIRING TO SEE IF THERE MAY HAVE BEEN OTHER CLINICS REPORTING AN INCREASE IN THEIR ENDOPHTHALMITIS RATE AND ASSOCIATED WITH THE USE OF THESE SPECIFIC LOTS OF 30G NEEDLES.

  Patient problems: Endophthalmitis

  MAUDE report 22823815 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED ENDOPHTHALMITIS. EVENT DESCRIPTION: MATERIAL # 305106. BATCH # 4060059, 4031552. MY NAME IS (B)(6), I'M A RETINAL TECHNICIAN, AND I'M SENDING THIS MESSAGE ON BEHALF OF (B)(6) AND IN REGARD TO THE 30G X 1/2 (0.3MM X 13MM) NEEDLES (REF - 305106). OVER THE PAST MONTH WE'VE SEEN AN INCREASE IN OUR ENDOPTHALMITIS RATE (THIS HAS BEEN IRRESPECTIVE OF CLINICIAN OR DRUG BEING GIVEN). SINCE THIS WAVE OF INFECTIONS, WE HAVE CHANGED ALL THE VARIABLES ON OUR END THAT WERE ABLE TO (I.E. THE MANNER IN WHICH WE NUMB PATIENTS, DISCARDING NUMBING DROPS, ETC). THE ONLY COMMON DENOMINATOR AMONGST ALL OF THESE INSTANCES IS THE BRAND OF AND LOT #S OF THE NEEDLES THAT HAS BEEN USED (LOTS 4060059 AND 4031552). WE'VE BEEN MONITORING THE WEBSITE AS WELL THE BD WEBSITE OF ALL RECALLS AND WE HAVEN'T SEEN ANY RECENT RECALLS WITH THESE SPECIFIC LOT'S (4060059 AND 4031552). WE'RE INQUIRING TO SEE IF THERE MAY HAVE BEEN OTHER CLINICS REPORTING AN INCREASE IN THEIR ENDOPHTHALMITIS RATE AND ASSOCIATED WITH THE USE OF THESE SPECIFIC LOT #'S OF 30G NEEDLES.

  Patient problems: Endophthalmitis

  MAUDE report 22823812 ↗
• MalfunctionJun 15, 2025Break; Break

  MATERIAL #305106. LOT #UNKNOWN. HIS SISTER WHO HAS ENDOMETRIOSIS HAD A GYNECOLOGICAL PROCEDURE WHERE THEY WERE INJECTING BOTOX AND THE NEEDLE BROKE. VERBATIM: RCC RECEIVED A COMPLAINT VIA CALL. REQUESTING IF THE PRECISION GLIDE NEEDLE (REF 305106) CONTAINS STAINLESS STEEL OR ANY FERROUS METALS. HIS SISTER WHO HAS ENDOMETRIOSIS HAD A GYNECOLOGICAL PROCEDURE WHERE THEY WERE INJECTING BOTOX AND THE NEEDLE BROKE. THEY CAN SEE THE 6MM PIECE IN X-RAY BUT HAVE BEEN UNSUCCESSFUL IN REMOVING IT. SHE HAS HAD TWO EXPLORATORY PROCEDURES SO FAR. ADDITIONAL INFORMATION 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 2023. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? NA. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. YES, THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING A GYN PROCEDURE. THE PATIENT IS STILL NEEDING TO HAVE NEEDLE REMOVED AND WAS INQUIRING ABOUT THE TYPES OF MATERIAL THE PRODUCT IS MADE WITH.

  Patient problems: Foreign Body In Patient

  MAUDE report 22208674 ↗
• MalfunctionApr 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL #305106, POTENTIAL BATCH # 3334821, 3144657, 3209277. IT WAS REPORTED BY THE CUSTOMER THAT THE ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON 15JAN2025, WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM- SYRINGE. ON 27JAN2025, ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. INJECTION NEEDLE, CATALOG: 305106, LOT: 3334821. CUSTOMER RESPONDED ON 18-APR: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 15JAN2025. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A. 3. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE TO SEND TO BD FOR INVESTIGATION? SAMPLE WILL NOT BE FORWARDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933989 ↗
• MalfunctionApr 10, 2025Material Puncture/Hole; Material Puncture/Hole

  MATERIAL # 305106, BATCH # 4116511. IT WAS REPORTED BY THE CUSTOMER THAT MANY ARE PLUGGED AND WON'T WORK AND SOME HAVE A HOLE IN THE SIDE SO THE LIDOCAINE SHOOTS OUT THE SIDE. VERBATIM: JUST WANTED TO LET YOU KNOW THAT OUR 30 GAUGE NEEDLES HAVEN'T BEEN THE BEST QUALITY. MANY ARE PLUGGED AND WON'T WORK AND SOME HAVE A HOLE IN THE SIDE SO THE LIDOCAINE SHOOTS OUT THE SIDE. I HAD THIS HAPPEN 3 TIMES IN THE PAST 3 HRS THIS MORNING, BUT IT HAS BEEN A DAILY OCCURRENCE. ADDITIONAL INFORMATION RECEIVED ON 08APR2025. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE "MANY ARE PLUGGED AND WON'T WORK"? OUR SURGEON SAID THAT THEY ARE HAVING CONSISTENT ISSUES WITH THIS BRAND. 30 GAUGE NEEDLES HAVEN'T BEEN THE BEST QUALITY. MANY ARE PLUGGED AND WON'T WORK AND SOME HAVE A HOLE IN THE SIDE SO THE LIDOCAINE SHOOTS OUT THE SIDE. IT HAPPENED 3 TIMES IN THE PAST 3 HRS THIS MORNING, BUT IT HAS BEEN A DAILY OCCURRENCE." 2. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER OF THE PRODUCT ASSOCIATED WITH REPORTED ISSUE? YOUR 305106, MY ORACLE 102269. 3. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE PRODUCT ASSOCIATED WITH REPORTED ISSUE? THE LOT THAT IS CAUSING US ISSUES IS 4116511 AND PREVIOUSLY GIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814778 ↗
• MalfunctionMar 27, 2025Leak/Splash; Leak/Splash

  DESCRIPTION: MATERIAL #:305106, BATCH#:4116510. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE BEEN HAVING AN ISSUE WITH THE BD PRECISIONGLIDE NEEDLE WHERE WE HAVE A SECOND STREAM EXITING FROM THE SIDE OF THE NEEDLE WHEN WE INJECT. WE ENCOUNTERED THE ISSUE A SECOND TIME TODAY AFTER INITIALLY HAVING THIS ISSUE ABOUT A MONTH AGO. THE LOT NUMBER IS 4116510. ADDITIONALLY, THERE HAVE BEEN OTHER TIMES, PERHAPS 3, WHEN THE NEEDLE FEELS LIKE IT IS PLUGGED AND WE ARE UNABLE TO INJECT THE MEDICATION. PLEASE LET ME KNOW IF THERE IS ANY OTHER INFORMATION WE CAN PROVIDE. DATE OF EVENT WAS ON THURSDAY, (B)(6) 2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706862 ↗
• MalfunctionMar 4, 2025Complete Blockage; Complete Blockage

  MATERIALS: 305106. BATCH#: 4159365. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. REPORTED DEFECTIVE ITEM - CLOGGED NEEDLE LOT # 4159365.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513917 ↗
• MalfunctionFeb 25, 2025Material Discolored; Material Discolored

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458133 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications