N/A 305128Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00382903051281), received between Oct 27, 2017 and Apr 21, 2026 — classified as 9 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Break

  IT IS REPORTED, THE NEEDLE BROKE OFF INTO THE PATIENT. THE MD WAS MADE AWARE. MD PERFORMED ULTRASOUND GUIDED EXCISION TO REMOVE THE NEEDLE TIP BUT DID NOT SEE THE NEEDLE IN EXCISED TISSUE. TISSUE WAS SENT TO THE LAB. PATIENT WAS TRANSFERRED TO EMERGENCY DEPARTMENT TO PROVIDE FURTHER ASSISTANCE WITH FOREIGN BODY REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24940422 ↗
• InjuryApr 15, 2026Break

  IT IS REPORTED, NEEDLE BROKEN INSIDE PATIENT. VERBATIM: WAS PERFORMING TRIGGER POINT INJECTIONS (TPIS) FOR PATIENTS LEFT LOWER EXTREMITY MYOFASCIAL PAIN AND WHILE PERFORMING TPI IN PROXIMAL LEFT HAMSTRING PATIENT REACTED DUE TO PAIN AND 30 G 1 INCH NEEDLE BROKE OFF INSIDE PATIENT. WE WERE UNABLE TO RETRIEVE THE NEEDLE AND AREA WHERE IT WAS INSERTED WAS CIRCLED AND RECOMMENDED THE PATIENT PRESENT TO ED FOR FURTHER EVALUATION AND MANAGEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24884822 ↗
• MalfunctionMay 22, 2025Material Separation; Material Separation

  VERBATIM/EVENT DETAILS: MATERIAL # 305128 LOT # 4159370 I AM WRITING TO REPORT A RECENT INCIDENT INVOLVING A 30-GAUGE NEEDLE THAT BROKE OFF AT THE HUB DURING LOCAL INFILTRATION OF A PATIENT'S BREAST IN PREPARATION FOR ASPIRATION OF A HEMATOMA. THE NEEDLE DETACHED AT THE HUB WHILE NUMBING FATTY BREAST TISSUE, RAISING CONCERNS ABOUT PRODUCT INTEGRITY. ADDITIONAL INFORMATION THE PT HAD TO BE TAKEN TO THE OPERATING ROOM FOR SURGERY THE NEXT DAY TO REMOVE THE RETAINED NEEDLE. THE HARM WOULD BE A SURGICAL PROCEDURE TO REMOVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22069879 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  MATERIAL#: 305128. BATCH#: 1335520. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME APART FROM HUB WHERE IT IS NORMALLY GLUED IN PLACE. VERBATIM: PLEASE SEE PRODUCT COMPLAINT FROM BELOW, PLEASE REPORT AT ONCE. ANY KNOWN ISSUES WITH THE LOT NUMBER BELOW? INTERNAL DOCUMENTATION: (B)(4). DATE OF EVENT 3/4/2025. SITE: (B)(6). DEPARTMENT: URGENT CARE. NO HARM TO PATIENT. DESCRIPTION: NEEDLE CAME APART FROM HUB WHERE IT IS NORMALLY GLUED IN PLACE. LEADER NOTIFIED (B)(6) TO DETERMINE WHAT TO DO WITH BOX. BOX REMOVED FROM INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751866 ↗
• MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

  MATERIAL # 305128 LOT # 4135785 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IT IS MORE THAN 15 NEEDLES THAT WE HAVE WHICH REMAIN BLOCKED, THE PASSAGE OF LIQUID DOES NOT DO ORIGINAL FRENCH: CELA FAIT PLUS DE 15 AIGUILLES QUE NOUS AVONS QUI RESTENT BLOQUER, LE PASSAGE DU LIQUIDE NE CE FAIT PAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283259 ↗
• InjuryDec 21, 2024Break; Break

  MATERIAL # 305128; BATCH # 3055909. VERBATIM: THE NEEDLE BROKE OFF AT THE HUB UNDER THE PATIENT'S SKIN. IT WAS STOCKED IN THE BGH PLASTICS OFFICE AND BROUGHT TO THE OR TO BE USED FOR A PROCEDURE THERE. THE PROVIDER WAS ABLE TO REMOVE THE NEEDLE IN THE OR. THE NEEDLE WAS BEING USED FOR INJECTION IN THE FACE. THERE WAS AN UNEXPECTED INCISION NEEDED TO RETRIEVE THE BROKEN PORTION OF THE NEEDLE. THERE WAS A DELAY IN THE NORMAL PROGRESSION OF THE CASE DUE TO NEEDING TO RETRIEVE THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20996879 ↗
• MalfunctionDec 6, 2024Break; Break

  MATERIAL#: 305128; BATCH#: 3083963. VERBATIM: 3 OF THE NEEDLES HAVE NOT BEEN WORKING PROPERLY AND THE PLASTIC IS BREAKING WHEN INJECTING PATIENTS.

  Patient problems: Insufficient Information

  MAUDE report 20864321 ↗
• MalfunctionNov 25, 2024Complete Blockage; Complete Blockage

  MATERIAL#: 305128 BATCH NUMBER#: 3024960 IT WAS REPORTED BY CUSTOMER THAT WHEN INJECTING LIDOCAINE FOR LOCAL ANESTHESIA IN PREPARATION FOR A MOHS REPAIR ON A PATIENT HOWEVER HAD 2 NEEDLES PLUGGED AND UNABLE TO PUSH OUT ANY LIDOCAINE. VERBATIM#: DR. X WAS INJECTING LIDOCAINE FOR LOCAL ANESTHESIA IN PREPARATION FOR A MOHS REPAIR ON A PATIENT HOWEVER HAD 2 NEEDLES PLUGGED AND UNABLE TO PUSH OUT ANY LIDOCAINE. THE 2 NEEDLES WERE FROM THE SAME LOT BATCH: BD PRECISION GLIDE NEEDLE 30 G 1 INCH NEEDLE LOT #3024960. THE DEFECTED NEEDLES WERE PLACED IN THE SHARPS BIN. NEW NEEDLES FROM THE SAME LOT BATCH WERE PLACED ON THE SYRINGE AND WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771008 ↗
• MalfunctionOct 7, 2024Complete Blockage; Complete Blockage

  MATERIAL #: (B)(4). BATCH#: (B)(4), (B)(4). IT WAS REPORTED BY CUSTOMER THAT THESE NEEDLES ARE USED BY A PHYSICIAN WHO RUNS A PAIN CLINIC HERE AT OUR FACILITY AND HE HAS INDICATED THAT SOME OF THEM ARE OBSTRUCTED. ON AVERAGE HE USES APPROXIMATELY 60 PER WEEK AND OF THOSE, HE IS REPORTING THAT 2-3 ARE USUALLY OBSTRUCTED. HE HAS BEEN USING THESE NEEDLES FOR SEVERAL YEARS NOW AND HAS NEVER HAD ANY PROBLEMS UNTIL THIS SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383273 ↗
• InjurySep 18, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305128. BATCH # 3055909. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE ITSELF BROKE OFF FROM THE HUB AND BECAME EMBEDDED WITHIN THE PATIENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: (B)(6) 2024. COMPLAINT NUMBER: (B)(4). ACCOUNT NAME: (B)(6). CONTACT PERSON: (B)(6). ITEM DESCRIPTION: NEEDLE,SPCLTY HYPO,30GX1",RG BVL,STL. INCIDENT DESCRIPTION: NEEDLE BROKE OFF AND EMBEDDED. INJURIES OR ADVERSE EVENT: NO. ITEM: 305128. QUANTITY AFFECTED: 1 EA. SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: WE UNFORTUNATELY ENCOUNTERED A SIGNIFICANT PRODUCT MALFUNCTION YESTERDAY THAT CAUSED A PATIENT SAFETY ISSUE. MY PARTNER, (B)(6) (CC'D ON THIS EMAIL), WAS PERFORMING AN INJECTION ON A PATIENT USING A BECTON- DICKINSON 30G 1-INCH NEEDLE FROM OUR (B)(6) 2024 ORDER - (B)(6) CONSERVATIVELY ESTIMATING, HE HAS PERFORMED HUNDREDS OF INJECTIONS USING THIS SIZE NEEDLE OVER THE PAST 7 YEARS. DURING THE INJECTION, THE NEEDLE ITSELF BROKE OFF FROM THE HUB AND BECAME EMBEDDED WITHIN THE PATIENT. THE PATIENT HAD TO BE SENT TO THE EMERGENCY ROOM FOR AN EXCISION AND REMOVAL OF THE NEEDLE. WE NEED TO FILE AN I

  Patient problems: Foreign Body In Patient

  MAUDE report 20246868 ↗
• MalfunctionSep 18, 2024Complete Blockage; Complete Blockage

  MATERIAL#: 305128. BATCH NUMBER#: 3024960. IT WAS REPORTED BY CUSTOMER THAT 30G NEEDLE IS USED FOR INITIAL LOCAL ANESTHETIC. THE PROVIDER WAS UNABLE TO PUSH MEDICATION THROUGH NEEDLE. ADDITIONAL INFORMATION: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT¿. NO PATIENT HARM, THE ONLY IMPACT WAS A SLIGHT DELAY IN TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245440 ↗
• MalfunctionAug 22, 2024Complete Blockage; Complete Blockage

  MATERIAL # 305128, BATCH # 3083963. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES WERE BLOCKED AND LOOKED SOLID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: 08/07/2024. COMPLAINT NUMBER: (B)(4). ACCOUNT NUMBER: (B)(6). ACCOUNT NAME: XXX. CONTACT PERSON: XXX. ITEM NUMBER: 308-305128. LOT NUMBER: 3083963. SAMPLE AVAILABLE: CONFIRMING. ITEM DESCRIPTION: NDL BD SPECIALTY REG BVL 30GX1" STER. INCIDENT DESCRIPTION: AS PER ACCOUNT, WE HAD APPROXIMATELY 10-15 FAULTY 30 G NEEDLES FROM THE LAST ORDER OF 4 BOXES. THE NEEDLES WERE BLOCKED AND LOOKED SOLID. IT'S A SMALL NUMBER, BUT IT'S NOT SOMETHING I HAVE ENCOUNTERED BEFORE, EITHER IN MY OFFICE OR AT THE HOSPITAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030077 ↗
• MalfunctionMay 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ADDITIONAL INFORMATION RECEIVED: NO PATIENT HARM: MATERIAL# 305128 BATCH# 3024960 IT WAS REPORTED BY CUSTOMER THAT NEEDLE IN THE BOX WOULD NOT RELEASE THE MEDICATION, AND EVERY 3RD NEEDLE OR SO WILL NOT STAY ON THE SYRINGE. VERBATIM: BD PRECISIONGLIDE NEEDLE 30G X 1, #305128 WITH LOT#3024960, IS REPORTED TO BE DEFECTIVE MY A PHYSICIAN OFFICE PLACING BOTOX INJECTIONS. AT LEAST 1 NEEDLE IN THE BOX WOULD NOT RELEASE THE MEDICATION, AND EVERY 3RD NEEDLE OR SO WILL NOT STAY ON THE SYRINGE. STAFF ARE FLUSHING WITH SALINE PRIOR TO DRAWING UP AND ADMINISTERING THE RX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250209 ↗
• MalfunctionMay 6, 2024Break; Break

  MATERIAL#: 305128, BATCH#: 3024960. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE 30G NEEDLE BROKE OFF IN PATIENT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING NEEDLE 30G BROKE OFF IN PATIENT. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. VENDOR PART #: 305128 LOT NUMBER #: 3024960 ADDITIONAL INFORMATION RECEIVED ON 02-MAY-2024 HOW WAS THE NEEDLE REMOVED FROM PATIENT? NOT SPECIFIED WHEN DOES THIS EVENT HAPPENED? I.E. DATE OF EVENT? (B)(6) 2024. WAS THERE ANY PROCEDURE REQUIRED FOR REMOVAL OF NEEDLE? NOT SPECIFIED HOW WAS THE PATIENT OUTCOME? PATIENT IS DOING GOOD AND THERE WAS NO HARM WAS THE PROCEDURE CARRIED OUT BY A REGISTERED HEALTH PRACTITIONER? YES PLEASE PROVIDE ADDRESS OF THE FACILITY WHERE THE INCIDENT HAS OCCURRED. IT WAS NOTED THAT THERE IS A SAMPLE AVAILABLE FOR INVESTIGATION COULD YOU PLEASE PROVIDE THE ADDRESS WHERE THE SAMPLE IS AVAILABLE FOR INVESTIGATION?

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19248034 ↗
• MalfunctionMar 6, 2024Complete Blockage; Complete Blockage

  MATERIALS#: 305128, BATCH#: 3024960. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES ARE COMPLETELY CLOGGED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PIR ATTACHED. COMPLAINT NO.: (B)(4). DATE OF INCIDENT: (B)(6) 2024. ACCOUNT NUMBER: (B)(4). CLIENT'S NAME: (B)(6). PRODUCT NO.: 305128. PRODUCT DESCRIPTION: BD 30GX1" NEEDLE. SERIAL NO. /LOT: (B)(6). QUANTITY: 1 BX. DESCRIPTION: A DOZEN DEFECTIVE NEEDLES, THE NEEDLES ARE COMPLETELY CLOGGED OR WITH A SCRATCHED BEVEL. RESPONSE RECEIVED. PLEASE FIND BELOW THE REQUESTED INFORMATION: NO ADVERSE EVENTS OR SERIOUS INJURIES HAVE BEEN REPORTED BY PATIENTS OR HEALTHCARE PROFESSIONALS. THE NEEDLES NEED TO BE REPLACED EITHER DUE TO BLOCKAGE OR POOR TISSUE PENETRATION CAUSED BY CLOGGED TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845656 ↗
• MalfunctionFeb 21, 2024Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED MATERIAL# : 305128 LOT#: 3024960 IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CLOGGED NEEDLES AND UNABLE TO INJECT TO PATIENT VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLIANT CREATED 2ND CUSTOMER: (B)(6). WE HAVE HAD COMPLAINTS FROM 2 CUSTOMERS REGARDING THE 305128 ¿ 30G X 1¿ HYPO NEEDLES ¿ LOT 3024960 SOME OF THE NEEDLES WERE CLOGGED AND NOT ABLE TO INJECT THE PATIENT. NO STOCK LEFT TO SEND BACK FOR INVESTIGATION. NO INJURIES REPORTED TO PATIENTS. ADDITIONAL INFO RECEIVED ON 20-FEB-2024 ¿DOES BOTH CUSTOMERS BELONG TO SAME USER FACILITY? IF DIFFERENT, PLEASE PROVIDE DETAILS ¿ NO THEY ARE DIFFERENT FACILITIES ¿WHAT ARE THE DATE OF EVENTS FOR BOTH CUSTOMERS? 2/1/2024 AND 2/5/2024 ¿DO BOTH THE CUSTOMERS HAVE SAME BATCH NUMBERS? - YES ¿WAS THE PRODUCT RECEIVED IN THIS CONDITION? ¿ PRODUCT IS RECEIVED IN BY CIPM PACKAGED INTO PROCEDURAL KITS. THEY ARE NOT USED UNTIL IN THE FIELD AT CUSTOMER FACILITIES. ¿WHAT IS THE FULL NAME AND ADDRESS OF THE FACILITIES FOR WHERE THE ISSUES OCCURRED? (B)(6). ADDITIONAL INFORMATION RECEIVED ON 21-FEB-2023 PRODUCT WAS STORED IN A TEMPERATURE CONTROLLED WAREHOUSE. ¿WAS THIS ISSUE DISCOVERED BEFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753313 ↗
• MalfunctionFeb 21, 2024Complete Blockage; Complete Blockage

  MATERIAL# :305128 . LOT#:3024960. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CLOGGED NEEDLES AND UNABLE TO INJECT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18752721 ↗
• InjuryJan 30, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? YES. 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES- UNABLE TO ACCURATELY ASSESS AND TREAT PATIENT'S BACK PAIN. 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO. 4. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PATIENT IS GOING TO GET SCHEDULED TO HAVE THE NEEDLE SURGICALLY REMOVED NEXT WEEK. 5. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? PATIENT IS GOING TO GET SCHEDULED TO HAVE THE NEEDLE SURGICALLY REMOVED NEXT WEEK. 6. PATIENT STATUS? STABLE 7. ANY PICTURE OF THIS COMPLAINT - NO. 8.PLEASE EXPLAIN ELABORATE ISSUE? NEEDLE BROKE OFF FROM HUB DURING PROCEDURE. 9. DATE OF EVENT? (B)(6) 2024. 10.PHYSICAL AVAILABLE/NOT AVAILABLE? NOT AVAILABLE MATERIAL#: 305128 BATCH#: 2363618 IT WAS REPORTED BY CUSTOMER THAT NEEDLE WAS BEING USED FOR TRIGGER POINT INJECTIONS TO THE LOW BACK REGION (MIDLINE). A SNAP WAS HEARD DURING THE TRIGGER POINT INJECTION THE SYRINGE WAS RETRACTED AND THE NEEDLE REMAINED IN THE PATIENT. THERE WERE NO VISIBLE FRAGMENTS OF NEEDLE AFTER THE SNAP WAS HEARD. A SCAPPL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18606315 ↗
• InjuryAug 28, 2023Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE OFF INTO THE PATIENT AFTER INJECTING DILUTE CONTRAST. A GENERAL SURGEON WAS CALLED IN TO REMOVE THE NEEDLE, BUT THE FIRST ATTEMPT WAS UNSUCCESSFUL. A SECOND ATTEMPT WITH FLUOROSCOPIC GUIDANCE WAS SUCCESSFUL AT REMOVING THE BROKEN NEEDLE, AND TWO X-RAYS WERE PERFORMED TO MONITOR THE PATIENT'S CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADOLESCENT GIRL WITH BYLER'S DISEASE AND COMPLEX HX WITH EWINGS SARCOMA OF THE CHEST WALL. PATIENT PRESENTED TODAY TO IR FOR A CT GUIDED RIGHT CHEST WALL LESION BIOPSY. ATTENDING WAS BIOPSYING A SMALL PLEURAL NODULE IN THIS PATIENT WITH HISTORY OF EWINGS SARCOMA. TO AVOID PUNCTURING THE LUNG AND CAUSING A PNEUMOTHORAX, INJECTED DILUTE CONTRAST INTO THE PLEURAL SPACE TO PUSH THE LUNG AWAY (HYDRODISSECTION). USED A SMALL NEEDLE (30 GAUGE). WHEN TRYING TO PULL OUT THE NEEDLE, IT SNAPPED OFF AT THE HUB LEAVING ONE PIECE EXTENDING THROUGH THE NODULE INTO THE PLEURAL SPACE. IT WAS NOT PROTRUDING THROUGH THE SKIN. UNSUCCESSFUL AT REMOVAL OF NEEDLE, GENERAL SURGERY CAME TO THE CT SCANNER. WHILE WAITING FOR SURGERY, MD PROCEEDED WITH THE BIOPSY. SURGEON ATTEMPTED TO REMOVE

  Patient problems: Foreign Body In Patient

  MAUDE report 17638573 ↗
• MalfunctionJun 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 9 OF THE BD PRECISION GLIDE¿ NEEDLE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 9 OBSTRUCTED NEEDLES BD 30GX1" PER 2 NEEDLES; ALL FROM THE SAME BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056430 ↗
• InjuryMay 11, 2023Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE AND LODGED IN THE PATIENT'S HIP, REQUIRING AN MRI. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAVE A CUSTOMER WHO SENT AN EMAIL STATING THEY HAD A PATIENT WHO HAD PRODUCT CODE 305128 LODGED IN THEIR HIP AND THEY NEED TO DO AN MRI."

  Patient problems: Foreign Body In Patient

  MAUDE report 16914429 ↗
• MalfunctionFeb 23, 2023Missing Information; Missing Information

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427472 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD PRECISIONGLIDE¿ NEEDLES BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PHYSICIANS IN THE ER ARE HAVING ISSUES WITH STICKING PATIENTS WITH THE NEEDLES, THAT THEY KEEP BREAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944797 ↗
• InjuryNov 23, 2022Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE FROM THE HUB INTO THE PATIENT DURING THE ANESTHETIC INJECTION. AS A RESULT, THE PATIENT REQUIRED AN X-RAY AND EXCISION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKE OFF FROM THE HUB IN THE PATIENT WHILE THEY WERE USING ANESTHETIC." "THE NEEDLE WAS LEFT IN THE PATIENT UPON DISCHARGE FROM THE OFFICE (B)(6) 2022. AN X-RAY WAS PERFORMED TO CONFIRM THE FOREIGN BODY, FOLLOWED BY AN EXCISION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859270 ↗
• MalfunctionJul 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE PULLED OUT OF THE HUB AFTER REMOVING THE CAP OF BD PRECISIONGLIDE¿ NEEDLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I PULLED THE CAP OFF A NEEDLE TO USE AND THE NEEDLE FELL RIGHT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058533 ↗

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