N/A 305109Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00382903051090), received between Oct 18, 2017 and Sep 14, 2026 — classified as 4 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (44 reports).

3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Leak/Splash; Material Twisted/Bent

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756489 ↗
• MalfunctionSep 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756488 ↗
• MalfunctionSep 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756194 ↗
• MalfunctionAug 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT IS REPORTED NEEDLE THROUGH SHIELD. EVENT DESCRIPTION: MATERIAL#: 305109. BATCH#: 3179204. WENT TO CLEAN UP AFTER A PROCEDURE AND GRABBED THE CAPPED NEEDLE WHICH WAS EXPOSED/PIERCED THROUGH THE CAP CAUSING A NEEDLE STICK. ADDITIONAL INFORMATION: PATIENT HAD TO BE CALLED BACK INTO THE OFFICE TO HAVE LABS DRAWN, CLINICIAN HAD TO ALSO HAVE LABS DRAWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22921545 ↗
• InjuryAug 1, 2025Material Perforation; Material Perforation

  IT IS REPORTED NEEDLE THROUGH SHIELD. EVENT DESCRIPTION: MATERIAL #305109 LOT #5064133. ON (B)(6) 2025 I GAVE MY WIFE AN INJECTION USING A BD 3ML SYRINGE AND BD PRECISION GLIDE 27G ½¿ NEEDLE. THIS IS A TASK THAT HAPPENS SOMEWHAT REGULARLY. UPON COMPLETION OF THE INJECTION, I WENT TO RECAP THE NEEDLE. THE NEEDLE CAP WAS LAYING ON THE COUCH NEXT TO HER. THE NEEDLE TIP CLEARED THE ENTRY TO THE CAP BY APPROXIMATELY HALF THE LENGTH OF THE NEEDLE ¿ ENOUGH TO WHERE I FELT COMFORTABLE TO COMPLETE THE RECAPPING WHILE THE CAP REMAINED ON THE COUCH. IN ATTEMPTING TO COMPLETE THE RECAPPING TO RENDER THE NEEDLE SAFE PRIOR TO MOVEMENT TO THE SHARPS CONTAINER, THE NEEDLE POKED THRU THE SIDEWALL OF THE NEEDLE CAP. THIS RESULTED IN A NEEDLE STICK INJURY TO MY LEFT INDEX FINGER. THE AMOUNT OF PRESSURE USED DURING THE RECAPPING WAS NOT OUT OF THE ORDINARY TO WHAT HAS TYPICALLY BEEN USED IN THE PAST ¿ THE CAP WAS NOT FORCED ON. I WANT TO MAKE YOU AWARE OF THIS INCIDENT SO THAT YOU CAN EVALUATE THE QUALITY OF THE PLASTIC IN THE CAP FOR THIS NEEDLE AND LOT. ADDITIONAL INFORMATION: THE ONLY MEDICAL INTERVENTION WAS A BANDAID. SINCE THIS WAS INITIALLY USED ON MY WIFE AND I KNOW HER MEDICAL HISTORY EXTREME

  Patient problems: Needle Stick/Puncture

  MAUDE report 22686477 ↗
• MalfunctionJul 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEEDLE 27X1/2 RB HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305109. BATCH#: 4212451. VERBATIM: (B)(4) REPORT. INCIDENT OR PROBLEM INFORMATION: (B)(4) REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT: (B)(6) 2025. SITE NAME/LOCATION: (B)(4). LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT (B)(4) OPTIONAL REPORT TO (B)(4) (HEALTH CANADA): INCIDENT DETAILS: CLIENT USED 3 ML BD LUER-LOK SYRINGE AND BD PRECISION GLIDE NEEDLE TIP TO SELF-INJECT MEDICATION. WHILE SELF-INJECTING, CLIENT NOTED THAT MEDICATION WAS LEAKING INTO LUER LOK HUB. WRITER NOTED THAT NEEDLE TIP WAS CORRECTLY ATTACHED AND SECURE. ASSISTED CLIENT IN CHANGING NEEDLE TIP. UNKNOWN SMALL AMOUNT OF MEDICATION WASTED IN LUER-LOK. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 3ML. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 309657. SERIAL OR LOT NUMBER: (B)(6). DEVICE EXPIRY DATE: 2025-10-31. SUPPLIER: (B)(4). SUPPLIER CATALOGUE NUMBER: (B)(4). WAS THE DEVICE RETAINED? NO. INVESTIGATION REQUEST: EXPECTED TYPE OF INVESTIGATION: LOT REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680841 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  DESCRIPTION: IT IS REPORTED NEEDLE BECAME LOOSE FORM HUB. EVENT DETAILS: MATERIAL # 305109 LOT # 4332075 WE HAD A SERIOUS LAB INCIDENT WHERE THE METAL PORTION OF A NEEDLE BECAME LOOSE AT THE BASE (SEE PICTURE BELOW) CAUSING POTENTIAL EXPOSURE TO HAZARDOUS MATERIAL FOR AN EMPLOYEE. FORTUNATELY, NONE OF OUR EMPLOYEES WERE HARMED BUT THIS CAUSED TESTING DELAYS, AND WE WERE REQUIRED TO REPORT THE INCIDENT PER FEDERAL REGULATIONS. WE STILL HAVE FIVE CASES OF THIS LOT UNUSED AND WAS WONDERING IF THERE ARE ANY KNOWN ISSUES FOR THIS LOT OR A RECALL SITUATION? WE WOULD AT LEAST LIKE TO REPORT IT TO THE MANUFACTURER JUST IN CASE. OCCURRENCE: 1 PATIENT IMPACTED? NO PATIENT IMPACT (DESC.): NO DATE OF EVENT: (B)(6) 2025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575423 ↗
• MalfunctionJan 13, 2025Complete Blockage; Complete Blockage

  MATERIAL#: 305109, BATCH#: 3347580, 4159372. " DR. (B)(6) USES A LARGE VOLUME OF THE PRECISION GLIDE 27G, ½ INCH NEEDLES IN CLINIC. SHE OPENED A FRESH BOX OF THEM THE OTHER DAY AND ALMOST ALL OF THEM AREN'T WORKING. WE OPENED A SECOND BOX TODAY WITH THE SAME LOT AND THOSE ALSO AREN'T WORKING SO WE'RE GOING TO ASSUME THE WHOLE LOT IS BAD." RESPONSE 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY FOR "SECOND BOX TODAY"? IF UNKNOWN, CAN STATE UNKNOWN. THE FIRST LOT WAS 12/12/2024 AND THE SECOND ONE WAS 12/30/2024. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PATIENTS ARE ALL OKAY, THEY TOOK MULTIPLE INJECTIONS TO GET THEIR FULL DOSE OF MEDICATION WHICH WAS AN UNEXPECTED INCIDENT. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NOT OTHER THAN THE MULTIPLE TIMES BEING STUCK. 4. ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? (B)(6). ADDITIONAL INFORMATION: DR. (B)(6) (OUR HAND SURGEON) USES THESE NEEDLES ON A DAILY BASIS FOR INJECTIONS IN THE HAND. SHE WAS ABLE TO DRAW UP MEDICATION THROUGH THE NEEDLE INTO THE SYRINGE AND THEN PRIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141620 ↗
• MalfunctionJan 13, 2025Complete Blockage; Complete Blockage

  MATERIAL #305109. BATCH #3347580, 4159372. VERBATIM: "DR. (B)(6) USES A LARGE VOLUME OF THE PRECISION GLIDE 27G, ½ INCH NEEDLES IN CLINIC. SHE OPENED A FRESH BOX OF THEM THE OTHER DAY AND ALMOST ALL OF THEM AREN¿T WORKING. WE OPENED A SECOND BOX TODAY WITH THE SAME LOT AND THOSE ALSO AREN¿T WORKING SO WE¿RE GOING TO ASSUME THE WHOLE LOT IS BAD." RESPONSE : 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY FOR "SECOND BOX TODAY"? IF UNKNOWN, CAN STATE UNKNOWN. THE FIRST LOT WAS 12/12/24 AND THE SECOND ONE WAS 12/30/24. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? ¿ PATIENTS ARE ALL OKAY, THEY TOOK MULTIPLE INJECTIONS TO GET THEIR FULL DOSE OF MEDICATION WHICH WAS AN UNEXPECTED INCIDENT. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? ¿ NOT OTHER THAN THE MULTIPLE TIMES BEING STUCK. 4. ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? ¿ (B)(6). ADDITIONAL INFORMATION: DR. (B)(6) (OUR HAND SURGEON) USES THESE NEEDLES ON A DAILY BASIS FOR INJECTIONS IN THE HAND. SHE WAS ABLE TO DRAW UP MEDICATION THROUGH THE NEEDLE INTO THE SYRINGE AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141588 ↗
• MalfunctionDec 21, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 20996684 ↗
• MalfunctionDec 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL# 305109. BATCH# 4178813. VERBATIM: I'M A RECENT CUSTOMER OF MDR PHARMACY. I RECEIVED THE BD PRECISIONGLIDE 27G X 1/2 NEEDLE AS PART OF THE MENOPUR INJECTION FOR IVF. I NOTICED MY NEEDLE TODAY HAD SOME WHITE PAINT-LIKE COATING ON ONE END, WHICH CAME CLOSE TO/MAY HAVE TOUCHED MY SKIN AT THE INJECTION SITE IN MY ABDOMEN. I WAS WONDERING WHAT IT IS, AND IF IT IS SAFE TO TOUCH THE SKIN/INJECTION AREA? SEE THE IMAGES ATTACHED, INCLUDING THE BATCH THIS NEEDLE IS PART OF. YOUR ADVICE IS APPRECIATED- THANK YOU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913157 ↗
• MalfunctionNov 20, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL #: 305109 AND BATCH#: 4107600. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE TO OCCASIONALLY PUNCTURE CAP AND CAUSE INJURY TO PERSON CAPPING THE NEEDLE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733022 ↗
• MalfunctionSep 17, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIALS#: 305109 BATCH#: 9269815. IT WAS REPORTED BY THE CUSTOMER THAT COMPLETED INJECTION SUCCESSFULLY, WENT TO RECAP NEEDLE AND NEEDLE PIERCED CAP WALL, RESULTING IN NSI. EMAIL FROM (B)(4): HI VENDOR REP, PLEASE FOLLOW UP WITH XXXX AT XXX-XXX-XXXX (EXT: ) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6)2024 HOSPITAL: (B)(6) HOSPITAL DEPARTMENT: (B)(6) CLINIC PRODUCT: BD PRECISION GUIDE NEEDLE VMID: (B)(4) LOT NUMBER: 9269815 PRODUCT EXPIRY DATE: 31-OCT-2024 NUMBER OF DEFECTIVE PRODUCT(S): 1 IS SAMPLE AVAILABLE: NO CONCERN DESCRIPTION: PRODUCT FAILURE THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN. EMAIL FROM XXXXX: HELLO, WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. XXXXXX REF(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER R

  Patient problems: Needle Stick/Puncture

  MAUDE report 20235739 ↗
• InjuryJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED WAS THE NEEDLE CONTAMINATED WITH BODY FLUID? YES. WERE THERE ANY MEDICAL INTERVENTIONS REQUIRED FOR THE NEEDLE STICK? NO. MATERIAL# 305109. BATCH# 3179204. IT WAS REPORTED BY CUSTOMER THAT PLACED CAP BACK ON NEEDLE THE NEEDLE PUSHED THROUGH THE PLASTIC COVER, CAUSING A NEEDLE STICK TO RN'S THUMB. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED WHEN THIS RN PLACED CAP BACK ON NEEDLE THE NEEDLE PUSHED THROUGH THE PLASTIC COVER, CAUSING A NEEDLE STICK TO RN'S THUMB. LOT NUMBER - 3179204.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19770614 ↗
• MalfunctionJun 14, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  ADDITIONAL INFORMATION RECEIVED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO APPARENT HARM. WHERE SPECIFICALLY WAS THE LEAKAGE? MEDICATION CAME OUT OF NEEDLE TIP AT THE HUB. MATERIAL #: 305109, BATCH#: 3179204. IT WAS REPORTED BY CUSTOMER THAT CLIENT USING BD PRECISION GLIDE NEEDLE TIP TO SELF-INJECT HIS NTS DOSE OF HYDROMORPHONE. WHEN BEGINNING TO INJECT, MEDICATION CAME OUT OF NEEDLE TIP AT THE HUB. NEW NEEDLE TIP PROVIDED, WHICH CLIENT WATCHED CLOSELY FOR ANY LEAKS. 2.75 BOXES OF THIS LOT OF NEEDLE TIPS WERE PULLED FROM THE NTS ROOM AND LABELED WITH "DO NOT USE,". MATERIAL - 305109, LOT - 3179204. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. CLIENT USING BD PRECISION GLIDE NEEDLE TIP TO SELF-INJECT HIS NTS DOSE OF HYDROMORPHONE. WHEN BEGINNING TO INJECT, MEDICATION CAME OUT OF NEEDLE TIP AT THE HUB. NEW NEEDLE TIP PROVIDED, WHICH CLIENT WATCHED CLOSELY FOR ANY LEAKS. 2.75 BOXES OF THIS LOT OF NEEDLE TIPS WERE PULLED FROM THE NTS ROOM AND LABELED WITH "DO NOT USE,". MATERIAL - 305109, LOT - 3179204.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538421 ↗
• MalfunctionJun 13, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL# 305109 BATCH# 3179204 IT WAS REPORTED BY CUSTOMER THAT THEY SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2024 SITE NAME/LOCATION: XXX LEVEL OF HARM: MINIMAL HARM AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: WHILE SELF-ADMINISTERING MEDICATION IV, CLIENT REPORTED MEDICATION LEAKED AT CONNECTION POINT BETWEEN NEEDLE TIP AND SYRINGE DESPITE BEING SECURELY ATTACHED. NOTED TO HAVE APPROXIMATELY 0.8 ML OF MEDICATION LEFT IN SYRINGE. DOSE SHOULD BE 1.4 ML. IMPACT OF INCIDENT: CLIENT RECEIVED LOWER DOSE THAN ORDERED. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC PRECISION GLIDE REGULAR BEVEL 27 GAUGE X 0.5 INCH MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 305109 SERIAL OR LOT NUMBER: 3179204 DEVICE EXPIRY DATE (YYYY-MM-DD UNKNOWN SUPPLIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527130 ↗
• MalfunctionJun 7, 2024Contamination; Contamination

  MATERIAL NUMBER: 305109; LOT NUMBER: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE IS MISSING AND THERE IS FOREIGN MATTER IN THE PACKAGING. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SPONTANEOUS PATIENT DID REPORT A MANUFACTURING DEFECT WITH THE NEEDLE, NEEDLE WAS NOT PRESENT AND THERE WERE BLACK SPECS INSIDE PACKING, UNKNOWN IF PATIENT MISSED DOSE. NO ADVERSE EVENT REPORTED. UNKNOWN IF PATIENT STILL HAS DEFECTIVE DEVICE ON HAND FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. CATLOG - 305109

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485246 ↗
• MalfunctionMay 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THERE WERE DEFECTS FOUND ON THE NEEDLES SUPPLIED BY BD (BD PRECISIONGLIDETM NEEDLE - NEEDLE 27GX1/2" 0.4MMX13MM) DURING REPACKAGING ACTIVITY AT ZUELLIG PHARMA SINGAPORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259275 ↗
• MalfunctionMar 18, 2024Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED. MATERIAL#:305109; LOT# 3194038. IT WAS REPORTED BY THE CUSTOMER THAT THE LIQUID DIDN'T COME OUT PROPERLY FROM SYRINGE AND THEY RECEIVED ONLY HALF THE DOSE INSTEAD. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER HAS PROBLEM WITH SYRINGE. LIQUID DIDN'T COME OUT PROPERLY FROM SYRINGE AND THEY RECEIVED ONLY HALF THE DOSE INSTEAD. PLEASE CONTACT CAROLINE AT 450 248 2892 FROM PHARMACY PROXIM PIER ALEXANDRE RIOUX IN BEDFORD - ASK FOR SHELLEY IF CAROLINE IS N/A SKU# 305109; LOT# 3194038; EXP 2028/08/31. FOLLOW UP: 1.PLEASE PROVIDE THE DATE OF EVENT. 3/1/2024. 2.PLEASE PROVIDE THE CUSTOMER ADDRESS. UPDATED. 3. IS THERE ANY PHYSICAL SAMPLE OR SAMPLE PHOTOS/VIDEOS AVAILABLE? IF YES, KINDLY SHARE IT FOR INVESTIGATION. NO.

  Patient problems: Insufficient Information

  MAUDE report 18920973 ↗
• MalfunctionFeb 12, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED. A BROKEN HUB. WHITE COLOURED SOLIDS FOUND ON NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684899 ↗
• MalfunctionFeb 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. A BROKEN HUB. WHITE COLOURED SOLIDS FOUND ON NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684851 ↗
• MalfunctionJan 17, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524966 ↗
• MalfunctionDec 11, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305109 BATCH#: 2279773, 1273599. IT WAS REPORTED BY CUSTOMER THAT WE'RE NOTICING SOME ISSUES WITH THE PD 27G X1/2 NEEDLES WE HAVE IN CLINIC. THEY SEEM TO BE CLOGGING AND I'VE BEEN TOLD IT'S HAPPENING WITH SEVERAL BOXES. SAMPLE LOCATION: 1048 INDEPENDENT AVE GRAND JUNCTION CO 81505-6175. VERBATIM: WE WOULD LIKE TO REPORT A PRODUCT DEFECT/COMPLAINT. PLEASE PROCESS CREDIT OR AN RMA FOR THIS PRODUCT FOR YOUR INVESTIGATION. KINDLY REFERENCE CUSTOMER¿S # AND CARDINAL CIF ON ALL EMAILS AND CORRESPONDENCE. CUSTOMER REFERENCE: (B)(4). CARDINAL PO: 4531395379. ITEM: 305109. CUSTOMER PO: 0000222574. LOT#: REF (B)(64) LOT: 2279773 AND REF (B)(4) LOT: 1273599. CASE INTAKE FORM SUBMITTED THRU CARDINAL: (B)(4). INITIAL REPORTER: (B)(6). DESCRIPTION AS REPORTED: WE'RE NOTICING SOME ISSUES WITH THE PD 27G X1/2 NEEDLES WE HAVE IN CLINIC. THEY SEEM TO BE CLOGGING AND I'VE BEEN TOLD IT'S HAPPENING WITH SEVERAL BOXES. SAMPLE LOCATION: 1048 INDEPENDENT AVE GRAND JUNCTION CO 81505-6175. FOR QUESTIONS ABOUT THE SAMPLE, HERE¿S THE CONTACT DETAILS OF THE CUSTOMER. (B)(6). FOR INFORMATION REGARDING CREDIT TO CARDINAL PO, PLEASE REPLY TO THIS EMAIL ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300356 ↗
• MalfunctionOct 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT 3 OF THE BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: 1 UNIT OF DIRTY NEEDLE. 2 UNITS OF DIRTY NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916710 ↗
• MalfunctionOct 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO OF THE BD SAFETYGLIDE¿ NEEDLE WERE LEAKING. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THE BIG PROBLEM IS THAT THERE IS A LEAK IN THE PLASTIC PART OF THE NEEDLE. THE LIQUID FLOWS AT THE END, BUT ALSO FROM THE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17870196 ↗

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-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• 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