N/A 305197Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00382903051977), received between Dec 14, 2017 and Sep 30, 2026 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (43 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947219 ↗
• MalfunctionSep 23, 2026Break

  It was reported, NEEDLE 16X1 RB, broken needle hub during use.The following was provided by the initial reporter: At our hospital we have had several instances of needles breaking apart when the needle is being injected into a vial. The needle is the BD Precision Glide Needle 16G X 1" Lot number 6175332, Exp 5/31/2031.Additional information:Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6)2026 and (b)(6)2026.As you mentioned "we have had several instances" Were there any events that were not reported to BD earlier? If yes kindly provide further details of the events not reported before. Several events happened t September 7th, however this was not reported to me until another event on September 14th.he week of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870805 ↗
• MalfunctionSep 23, 2026Break

  It was reported, NEEDLE 16X1 RB, broken needle hub during use.The following was provided by the initial reporter: At our hospital we have had several instances of needles breaking apart when the needle is being injected into a vial. The needle is the BD Precision Glide Needle 16G X 1" Lot number 6175332, Exp 5/31/2031.Additional information:Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2026.As you mentioned "we have had several instances" Were there any events that were not reported to BD earlier? If yes kindly provide further details of the events not reported before. Several events happened the week of (b)(6) however this was not reported to me until another event on (b)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868688 ↗
• MalfunctionSep 22, 2026Break

  It was reported, NEEDLE 16X1 RB, broken needle hub during use.The following was provided by the initial reporter: At our hospital we have had several instances of needles breaking apart when the needle is being injected into a vial. The needle is the BD Precision Glide Needle 16G X 1" Lot number 6175332, Exp 5/31/2031.Additional information:Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6)2026 and (b)(6)2026.As you mentioned "we have had several instances" Were there any events that were not reported to BD earlier? If yes kindly provide further details of the events not reported before. Several events happened the week of September 7th, however this was not reported to me until another event on September 14th.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855635 ↗
• MalfunctionMar 20, 2026Contamination

  IT IS REPORTED WHITE SPOT ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650683 ↗
• MalfunctionDec 3, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE BD NEEDLE 16X1 RB HAD EXCESSIVE EPOXY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. THE WHITE GLUE WHERE THE HUB AND NEEDLE MEET IS ALL OVER THE HUB OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710774 ↗
• MalfunctionOct 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD NEEDLE 16X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305197, BATCH # 4159416. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED A BD 16-GAUGE NEEDLE WAS FOUND TO HAVE VISIBLE PARTICULATE MATTER CONTAMINATION INSIDE THE PROTECTIVE SHEATH PRIOR TO USE. THE NEEDLE WAS NOT USED AND WAS IMMEDIATELY ISOLATED FOR INVESTIGATION. LOT #: 4159416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410092 ↗
• MalfunctionAug 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: MATERIAL#: 305197. BATCH#: 4332125. PACKAGE OF STERILE NEEDLES CONTAINED DEAD/BLOODY BUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811978 ↗
• MalfunctionJun 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION: IT WAS REPORTED BY THE CUSTOMER THAT IT LOOKS LIKE IT MAY BE DEBRIS OR AND INDENTATION -HARD TO TELL. VERBATIM: MATERIAL: 305197, BATCH#: 4247038. RCC RECEIVED A COMPLAINT VIA EMAIL. IV TECH TOOK NEEDLE OUT OF PACKAGE, ATTACHED TO SYRINGE THEN NOTICED A SPOT ON NEEDLE. IT LOOKS LIKE IT MAY BE DEBRIS OR AND INDENTATION -HARD TO TELL. SHE DID NOT COMPOUND WITH NEEDLE. SHE SENT IT OUT TO [REDACTED] AND ESCALATED ISSUE. THERE ARE 2 NEEDLES. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 04-03-2025. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE REPORTED. 3. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? NONE TO SHARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208692 ↗
• MalfunctionMar 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL #:305197. BATCH#:4305182. IT WAS REPORTED BY CUSTOMER THAT A WHITE SUBSTANCE SHOT OUT AND IT THE PHARMACIST. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED A REPORT FROM OUR (B)(6) CONCERNING AN EVENT THEY HAVE EXPERIENCED WHILE USING A NEEDLE HYPO NONSAFETY STR 16G X 1IN (REFERENCE (B)(4)). THE LOT NUMBER IS 4305182. THE EVENT DATE IS 03.21.2025. NO HARM TO THE PATIENT HAS BEEN REPORTED. THE SAMPLE IS SEQUESTERED TO CONDUCT AN ANALYSIS TO DETERMINE THE ROOT CAUSE OF THE FAILURE. PLEASE LET ME KNOW THE NEXT STEP. WE ARE WILLING TO SEND THE SAMPLE. PLEASE HAVE AN RMA AND MAILER LABEL SENT TO MY ATTENTION. THE COMPLAINT IS DESCRIBED: UPON OPENING A BD PRECISION GLIDE NEEDLE 16GX 1", A WHITE SUBSTANCE SHOT OUT AND IT THE PHARMACIST. POSSIBLE PLASTIC. (B)(4). THANK-YOU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708973 ↗
• MalfunctionFeb 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL #305197 LOT #4247038 VERBATIM: RCC RECEIVED A COMPLAINT VIA CHAT. CUSTOMER NOTICED A DARK COLORED DEBRIS ON THE TIP OF THE NEEDLES. REF NUMBER: 305197; LOT NUMBER: 4247038. IT WAS OBSERVED BEFORE BEING USED ON A PATIENT. CUSTOMER RESPONSE RECEIVED ON FEB 14: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT, 31-01-2025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400374 ↗
• MalfunctionJan 22, 2025Contamination; Defective Component; Contamination; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207052 ↗
• MalfunctionJan 15, 2025Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158137 ↗
• MalfunctionJan 14, 2025Contamination; Contamination

  MATERIAL # 305197, LOT # 4158696. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE PHARMACY TEAM HERE ORDERS A BD NEEDLE AND FOUND THAT SOME NEEDLES HAVE HAD THIS WHITE POWDER COATING AND NEEDLE MIS MATCHED. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? DECEMBER 31, 2024. 2. PLEASE SHARE THE MATERIAL & LOT NUMBER ASSOCIATED WITH REPORTED ISSUE ¿ BD PRECISION GLIDE NEEDLE 16G LOT 4158696. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE. 4. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES ¿ (B)(6). 5. AS YOU MENTIONED 'NEEDLE MIS MATCHED', WE OBSERVED FROM THE PICTURE THAT THE NEEDLE WAS MISSING FROM THE PACKAGE. COULD YOU PLEASE CONFIRM IF THE MISSING NEEDLE IS THE ISSUE YOU ARE REPORTING? ONE NEEDLE WAS MISSING, AND 2 NEEDLES WERE FOUND WITH A WHITE SUBSTANCE ON THEM. ONE WAS DISCARDED, ONE IS AVAILABLE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147674 ↗
• MalfunctionDec 16, 2024Contamination; Contamination

  MATERIALS: 305197 BATCH#: 4116566. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. APPROXIMATELY 4,000 16G 1" NEEDLES FOUND WITH WHAT APPEARS TO BE INK ON THE TIP OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20942055 ↗
• MalfunctionSep 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL #: 305197, BATCH#: 4060205. IT WAS REPORTED BY CUSTOMER THAT NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278233 ↗
• MalfunctionAug 28, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION RECEIVED: MATERIAL #: 305197, BATCH#: 3334871. IT WAS REPORTED BY CUSTOMER THAT BLACK SPECKS FOUND IN BD 16 GAUGE 1" COMPOUNDING NEEDLES MULTIPLE NEEDLES OF LOT 3334871 FOUND WITH TINY BLACK SPECKS INSIDE OF LUER LOCK OR CAP OF PACKAGED NEEDLES. POTENTIAL STERILITY/CONTAMINATION ISSUE DURING COMPOUNDING OF STERILE IV PRODUCTS, WHICH MAY HAVE ALREADY OCCURRED. ALL NEEDLES WITH SPECIFIC LOT/EXPIRATION OF 3334871/[REDACTED DATE] WERE SEGREGATED AND ISOLATED FROM MAIN SUPPLY. AWAITING INVESTIGATION." MANUFACTURER RESPONSE FOR 16 GAUGE 1" COMPOUNDING NEEDLES, 16 GAUGE 1" COMPOUNDING NEEDLES (PER SITE REPORTER) MFG LETTER OF INVESTIGATION ATTACHED, NO FINDINGS, LOT COMPLIED WITH QC. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM# 305197. BLACK SPECKS FOUND IN. BD 16 GAUGE 1" COMPOUNDING NEEDLES. MULTIPLE NEEDLES OF LOT 3334871 FOUND WITH TINY BLACK SPECKS INSIDE OF LUER LOCK OR CAP OF PACKAGED NEEDLES. POTENTIAL STERILITY/CONTAMINATION ISSUE DURING COMPOUNDING OF STERILE IV PRODUCTS, WHICH MAY HAVE ALREADY OCCURRED. ALL NEEDLES WITH SPECIFIC LOT/EXPIRATION OF 3334871/[REDACTED DATE] WERE SEGREGATED AND ISOLATED FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084839 ↗
• MalfunctionJun 6, 2024Break; Break

  MATERIAL# 305197 BATCH# 3320201 IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES WERE BENT AND BROKEN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAVE PRODUCT THAT IS NON-CONFORMING, UNDER COMPLAINT NUMBER (B)(4). LOT 3320201 IS DEFECTIVE. BENT AND BROKEN NEEDLES. WE WOULD LIKE TO RETURN ALL ITEMS UNDER THIS LOT NUMBER FOR CREDIT. WE HAVE PRODUCT IN OUR JACKSONVILLE, FL LOCATION: VENDOR ITEM: 305197 LOT #: 3320201 QTY: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475823 ↗
• MalfunctionMay 31, 2024Break; Break

  MATERIAL# 305197, BATCH# 3320201. IT WAS REPORTED BY CUSTOMER THAT DAMAGED NEEDLES VERBATIM: DAMAGED NEEDLES (BROKEN, HAD BENT TIPS, AND HAD DAMAGE TO THE MIDDLE OF THE NEEDLE.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19433749 ↗
• MalfunctionMay 24, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED . MATERIAL# 305197. BATCH# 3320201. IT WAS REPORTED BY CUSTOMER THAT ONE NEEDLE WITH A BENT TIP, AND TWO BROKEN/CRACKED NEEDLES. VERBATIM. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE CUSTOMER REPORTED THAT THEY RECEIVED A BAD BATCH/LOT OF NEEDLES. FROM THAT BOX THEY HAD ONE NEEDLE WITH A BENT TIP, AND TWO BROKEN/CRACKED NEEDLES. THE CUSTOMER ADVISED THEY DISCARDED THE IMPACTED BOX/LOT AFTER OPENING AND DISCOVERING THIS ISSUE IMMEDIATELY (THE NEEDLES WERE NOT USED ON PATIENTS, THE DEFECTS WERE DISCOVERED UPON OPENING THE BOX. THE CUSTOMER ADVISED THEY HAVE TWO UNOPENED BOXES OF THE SAME LOT# THAT CAN BE RETURNED TO EVALUATE, HOWEVER THE ORIGINAL BOX WITH THE DEFECTS WAS DISCARDED. PRODUCT#: 305197. LOT#: 3320201.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390646 ↗
• MalfunctionMay 7, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL# 305197, BATCH# 3320201. IT WAS REPORTED BY CUSTOMER THAT BROWN COLORED DISCREPANCY WITHIN THE STERILE WRAPPING. IT APPEARS THAT A BROWN LIQUID DRIPPED INTO THE SAFETY CAP. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. S: A PHARMACY TECHNICIAN AT BRIDGEPORT HOSPITAL IDENTIFIED A POTENTIALLY ADULTERATED MEDICATION PRODUCT IN THE IV ROOM AT APPROXIMATELY 1600 ON (B)(6) 2024. B: THE BD PRECISIONGLIDE 16G X 1 INCH NEEDLE WITH LOT # 3320201 & EXP: 1/31/2029 WAS IDENTIFIED WITH A BROWN COLORED DISCREPANCY WITHIN THE STERILE WRAPPING. IT APPEARS THAT A BROWN LIQUID DRIPPED INTO THE SAFETY CAP. PRODUCT#: 305197, LOT#: 3320201.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258330 ↗
• MalfunctionMay 7, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED . MATERIAL # 305197, BATCH # 3320201. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES ARE BENT AT THE TIP AND SOME NEEDLES BROKE WHERE THE NEEDLE MEETS THE PLASTIC. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT THE NEEDLES ARE BENT AT THE TIP AND SOME NEEDLES BROKE WHERE THE NEEDLE MEETS THE PLASTIC. REF NUMBER: (B)(4); LOT NUMBER: 3320201. PLEASE INCLUDE (B)(6) IN ALL COMMUNICATION AS WELL AS (B)(6) EMAIL IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258302 ↗
• MalfunctionMay 3, 2024Break; Break

  MATERIAL: 305197 BATCH#: 3320201 IT WAS REPORTED BY THE CUSTOMER THAT STATED THAT THE NEEDLES WOULD BEND, SPLIT, AND SNAP OFF DURING USE ALLOWING THE DRUGS TO LEAK OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED MCKESSON¿S PRODUCT SAFETY REVIEW TEAM RECEIVED A PRODUCT COMPLAINT: 03/07/2024: XXXXX CUSTOMER SERVICE SPECIALIST AT THE XXXX (DC 8183) REPORTED TO THE PRODUCT SAFETY REVIEW TEAM (PSRT) THAT ON 03/07/2024 A CUSTOMER, XXXX, REPORTED FIVE (5) 100-COUNT BOXES OF 16G NEEDLES (UPC 08290305197)(LOT 3320201), MANUFACTURED BY XXXX, WHERE THE NEEDLES WERE DEFECTIVE. XXXX STATED THAT THE NEEDLES WOULD BEND, SPLIT, AND SNAP OFF DURING USE ALLOWING THE DRUGS TO LEAK OUT. ONE (1) WHOLE BOX HAD BEEN THROWN AWAY ALREADY AND XXX STILL HAS FOUR (4) BOXES. XXXX INSTRUCTED XXX TO REPORT THE EVENT TO THE MANUFACTURER. XXXX STATED THAT THEY WERE UNSURE HOW TO REPORT THE EVENT TO THE MANUFACTURER, HOWEVER THEY DID CONFIRM THAT THE BOXES SHOWED NO SIGNS OF TAMPERING. XXX STATED THAT THE MANUFACTURER WOULD BE CONTACTED AND ASKED SHANICE TO KEEP THE PRODUCT QUARANTINED.

  Patient problems: Insufficient Information

  MAUDE report 19238866 ↗
• MalfunctionMay 2, 2024Break; Break

  MATERIAL# 305197 BATCH # 3320201 IT WAS REPORTED BY CUSTOMER THAT BROKEN AT THE BASE RIGHT AFTER NEEDLE VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO MEDLINE NUMBER 200613171 ITEM: 305197 QUANTITY AFFECTED: 2 CASES SERIAL/LOT NUMBER: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: THE CRNA¿S ARE FINDING A LOT FROM SAME LOT ARE BROKEN AT THE BASE RIGHT AFTER NEEDLE WHEN THEY OPEN THEM UP FROM PACKAGING. I HAVE ONE IN MY POSSESSION AND HAVE ASKED THEM TO KEEP THEM AS THEY FIND THEM INSTEAD OF DISPOSING OF THEM. MULTIPLE CRNA¿S STATE THEY HAVE DISPOSED QUITE A FEW OF THEM OVER THE LAST WEEK SINCE THEY STARTED WITH THIS LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232593 ↗
• MalfunctionMay 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL # 305197 BATCH # 4046343 IT WAS REPORTED BY CUSTOMER THAT ISSUE WITH THE 16 G BD PRECISION GUIDE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE AN ISSUE WITH THE 16 G BD PRECISION GUIDE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229569 ↗

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