N/A 305198Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00382903051984), received between Mar 5, 2018 and Aug 14, 2025 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (30 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: MATERIAL # 305198, BATCH # 4159531, 4247109. REPORTED ISSUE: IT IS NOT EMBEDDED IN THE PLASTIC, AND IT DOES SCRAPE OFF. INJURIES OR ADVERSE EVENT: NO. ITEM: 305198. QUANTITIES AFFECTED: 2BX. ADDITIONAL INFORMATION I SENT THE EMAIL TO MEDLINE AFTER LEARNING THAT ADDITIONAL LOTS WERE IMPACTED. THE TWO ADDITIONAL LOTS WERE ALSO FOUND TO HAVE THE SAME DARK MATERIAL. CAN YOU PLEASE INCLUDE THESE ADDITIONAL LOTS TO THE REPORT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809100 ↗
• MalfunctionAug 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: MATERIAL # 305198 BATCH # 4159531, 4247109 REPORTED ISSUE: IT IS NOT EMBEDDED IN THE PLASTIC, AND IT DOES SCRAPE OFF. INJURIES OR ADVERSE EVENT: NO ITEM: 305198QUANTITY AFFECTED: 2BX ADDITIONAL INFORMATION I SENT THE ATTACHED EMAIL TO MEDLINE AFTER LEARNING THAT ADDITIONAL LOTS WERE IMPACTED. THE TWO ADDITIONAL LOTS WERE ALSO FOUND TO HAVE THE SAME DARK MATERIAL. CAN YOU PLEASE INCLUDE THESE ADDITIONAL LOTS TO THE REPORT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809097 ↗
• MalfunctionAug 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DESCRIPTION: IT IS REPORTED FOREIGN MATTER. EVENT DETAILS: IT WAS REPORTED BY CUSTOMER THAT "IT IS NOT EMBEDDED IN THE PLASTIC, AND IT DOES SCRAPE OFF.". INJURIES OR ADVERSE EVENT: NO. ITEM: 305198.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698202 ↗
• MalfunctionAug 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DESCRIPTION: IT IS REPORTED FOREIGN MATTER. EVENT DETAILS: IT WAS REPORTED BY CUSTOMER THAT "IT IS NOT EMBEDDED IN THE PLASTIC, AND IT DOES SCRAPE OFF." INJURIES OR ADVERSE EVENT: NO. ITEM: 305198.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698197 ↗
• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION: FOREIGN MATTER. VERBATIM: MATERIAL NO: 305198 BATCH NO: 4305226 ONE OF OUR PHARMACY TECHNICIANS WAS GETTING READY TO USE THIS NEEDLE TO PREPARE AN IV PRODUCT AND NOTICED A DARK SPOT, EITHER A CONTAMINANT OR A PLASTIC DEFECT, INSIDE THE HUB OF THE NEEDLE. IT WAS NOT USED FOR A PATIENT AND SO THERE WAS NO HARM. HE SET IT ASIDE WITHOUT USING IT AND CONTACTED ME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22449479 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  MATERIAL#: 305198, BATCH#: 5056705. IT WAS REPORTED BY CUSTOMER THAT THE SHAFT OF THE NEEDLE IS COMPLETELY SEPARATING FROM THE HUB "WE USE QUITE A LARGE AMOUNT OF THE #: 305198 16G 1.5" NEEDLES FOR STERILE COMPOUNDING - THIS WEEK THERE HAS BEEN A NUMBER OF REPORTS OF THESE NEEDLES BREAKING IN ATYPICAL FASHION. THE SHAFT OF THE NEEDLE IS COMPLETELY SEPARATING FROM THE HUB, WHICH IS A RISK FOR NEEDLESTICK INJURY." CUSTOMER RESPONSE RECEIVED ON 23-APR-2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? THE EVENTS OCCURRED ON TWO DIFFERENT DAYS, WITH TWO DIFFERENT TECHNICIANS MAKING TWO DIFFERENT COMPOUNDS. THE FIRST WAS ON OR AROUND MONDAY 04-07-2025 AND THE SECOND WAS ON FRIDAY 04-11-2025. 2. SAMPLE AVAILABILITY IS MENTIONED AS YES, PLEASE CHECK WITH CUSTOMER AND PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL ADDRESS: 3. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) BOTH CASES THE TECHNICIANS WERE UNHARMED AND ABLE TO MITIGATE A NEEDLESTICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909699 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  MATERIAL#: 305198, BATCH#: 5056705. IT WAS REPORTED BY CUSTOMER THAT THE SHAFT OF THE NEEDLE IS COMPLETELY SEPARATING FROM THE HUB. "WE USE QUITE A LARGE AMOUNT OF THE #: 305198 16G 1.5" NEEDLES FOR STERILE COMPOUNDING - THIS WEEK THERE HAS BEEN A NUMBER OF REPORTS OF THESE NEEDLES BREAKING IN ATYPICAL FASHION. THE SHAFT OF THE NEEDLE IS COMPLETELY SEPARATING FROM THE HUB, WHICH IS A RISK FOR NEEDLESTICK INJURY." CUSTOMER RESPONSE RECEIVED ON 23-APR-2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? THE EVENTS OCCURRED ON TWO DIFFERENT DAYS, WITH TWO DIFFERENT TECHNICIANS MAKING TWO DIFFERENT COMPOUNDS. THE FIRST WAS ON OR AROUND MONDAY 04-07-2025 AND THE SECOND WAS ON FRIDAY 04-11-2025. 2. SAMPLE AVAILABILITY IS MENTIONED AS YES, PLEASE CHECK WITH CUSTOMER AND PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL ADDRESS: 3. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) BOTH CASES THE TECHNICIANS WERE UNHARMED AND ABLE TO MITIGATE A NEEDLESTICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909685 ↗
• MalfunctionApr 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL#: 305198, BATCH#: 4159528, UNKNOWN, 4116660. IT WAS REPORTED BY THE CUSTOMER THAT THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS, CAUSING CONTAMINATION. RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEIR 16G NEEDLES HAVE CEMENT RUNNING DOWN THE NEEDLE AND CAUSES CONTAMINATION. SOMETIMES THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS AS WELL. 3 LOTS ARE AFFECTED. CUSTOMER HAS SAMPLES AND PICTURES AND VIDEOS TO SEND IT AS WELL. ADDITIONAL INFORMATION: LOT#: 4064535 ¿ APOLOGIES FOR THE CONFUSION. THIS SHOULD BE LOT#: 4064635. DATE OF DISCOVERY: ON (B)(6) 2025. HARM, INJURIES, COMPLICATIONS, NEG. OUTCOMES ¿ NONE OF WHICH WE ARE AWARE WE HAVE QUARANTINED THE AFFECTED LOTS IN OUR PHARMACY AND WILL WORK TO SHIP THEM TO BD WITH THE PROVIDED LABEL TODAY OR TOMORROW (ALONG WITH SEVERAL BAGS OF NEEDLES THAT WERE DISCOVERED WITH THE ISSUE IN QUESTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848694 ↗
• MalfunctionApr 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL # 305198 BATCH # 4159528, UNKNOWN,4116660. IT WAS REPORTED BY THE CUSTOMER THAT THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS, CAUSING CONTAMINATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED CUSTOMER STATES THAT THEIR 16G NEEDLES HAVE CEMENT RUNNING DOWN THE NEEDLE AND CAUSES CONTAMINATION. SOMETIMES THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS AS WELL. 3 LOTS ARE AFFECTED. CUSTOMER HAS SAMPLES AND PICTURES AND VIDEOS TO SEND IT AS WELL. ADDITIONAL INFORMATION LOT # 4064535 ¿ APOLOGIES FOR THE CONFUSION. THIS SHOULD BE LOT # 4064635 DATE OF DISCOVERY ¿ 04-04-2025 HARM, INJURIES, COMPLICATIONS, NEG. OUTCOMES ¿ NONE OF WHICH WE ARE AWARE WE HAVE QUARANTINED THE AFFECTED LOTS IN OUR PHARMACY AND WILL WORK TO SHIP THEM TO BD WITH THE PROVIDED LABEL TODAY OR TOMORROW (ALONG WITH SEVERAL BAGS OF NEEDLES THAT WERE DISCOVERED WITH THE ISSUE IN QUESTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848688 ↗
• MalfunctionApr 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL#: 305198, BATCH#: 4159528, UNKNOWN, 4116660. IT WAS REPORTED BY THE CUSTOMER THAT THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS, CAUSING CONTAMINATION. RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEIR 16G NEEDLES HAVE CEMENT RUNNING DOWN THE NEEDLE AND CAUSES CONTAMINATION. SOMETIMES THE CEMENT ON THE CONJUNCTION OF THE HUB AND NEEDLE IS LOOSE AND BREAKS AS WELL. 3 LOTS ARE AFFECTED. CUSTOMER HAS SAMPLES AND PICTURES AND VIDEOS TO SEND IT AS WELL. ADDITIONAL INFORMATION: LOT#: 4064535 ¿ APOLOGIES FOR THE CONFUSION. THIS SHOULD BE LOT#: 4064635. DATE OF DISCOVERY: ON (B)(6) 2025. HARM, INJURIES, COMPLICATIONS, NEG. OUTCOMES ¿ NONE OF WHICH WE ARE AWARE. WE HAVE QUARANTINED THE AFFECTED LOTS IN OUR PHARMACY AND WILL WORK TO SHIP THEM TO BD WITH THE PROVIDED LABEL TODAY OR TOMORROW (ALONG WITH SEVERAL BAGS OF NEEDLES THAT WERE DISCOVERED WITH THE ISSUE IN QUESTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848684 ↗
• MalfunctionApr 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION/EVENT DETAILS: THE CUSTOMER COMPLAINED THAT FOREIGN BODY WAS FOUND ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827382 ↗
• MalfunctionSep 17, 2024Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  OUR CUSTOMER TELLS US THAT THEY HAVE CHANGED THE MEASURES OF THIS KEY, WHEN CONVERTING FROM INCHES TO MILLIMETERS WE HAVE A DIFFERENCE OF 2 MM: 1.5 INCHES X 2.54 CM = 3.81 CM WOULD BE 38MM, BUT IN THE PRIMARY PACKAGING MENTIONS THAT ARE 40MM. NO OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238615 ↗
• MalfunctionMar 19, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 305198, BATCH #: 3299427. IT WAS REPORTED BY CUSTOMER THAT THERE IS A SIGNIFICANT INCREASE IN VIAL CORING WHEN USING NEEDLES IN PROPER TECHNIQUE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT NAME: BD PRECISION GLIDE NEEDLE. MATERIAL/CATALOG NUMBER: 305198. LOT NUMBER(S): 3299427. EVENT DESCRIPTION DATE OF INCIDENT (MM/DD/YYYY): ONGOING. DATE BD NOTIFIED, IF APPLICABLE (MM/DD/YYYY): 03/14/2024. NAME OF BD ASSOCIATE INFORMED, IF APPLICABLE (FIRST AND LAST NAME): N/A. DESCRIPTION OF EVENT (GIVE SPECIFIC AND OBJECTIVE DETAILS OF EVENT): SIGNIFICANT INCREASE IN VIAL CORING WHEN USING NEEDLES IN PROPER TECHNIQUE. SAMPLE AVAILABILITY (YES/NO INCLUDING PICK UP DETAIL INFORMATION): NO. WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? (GIVE DETAILED INFORMATION): N/A. ADDITIONAL KEY INFORMATION: DEATH INVOLVED YES/NO, SERIOUS INJURY, ERRONEOUS RESULTS, EXPOSURE TO BLOOD/BODILY FLUID, SAFETY ISSUE, OTHER TYPE OF ACTIONS TAKEN... SAFETY ISSUE; POTENTIAL FOR SIGNIFICANT PATIENT HARM; INSTRUCTED IV STAFF TO LOG SPECIFIC MEDICATION VIALS AND NEEDLES USED IN COMPOUNDS TO LOOK FOR ANY PATTERNS (LOT AND EXPIRATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934657 ↗
• MalfunctionMar 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. COMPLAINT FROM PRINCE OF WALES HOSPITAL. THE CUSTOMER COMPLAINED THAT WHITE FOREIGN BODIES WERE FOUND INSIDE THE CAP OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18930864 ↗
• MalfunctionFeb 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 305198 BATCH NUMBER#: 3291600 IT WAS REPORTED BY CONSUMER THAT THERE WERE ALSO A COUPLE OF NEEDLES THAT ON THE PURPLE ATTACHMENT HAD BLACK SPECKS IDENTIFIED UPON OPENING THE OVERWRAP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751804 ↗
• MalfunctionFeb 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED THE PRODUCT WAS NOT USED FOR ANY PREPARATION OR ON ANY PATIENT. MATERIAL#: 305198, BATCH NUMBER#: 3271988 , 3236172. IT WAS REPORTED BY CONSUMER THAT THERE WERE ALSO A COUPLE OF NEEDLES THAT ON THE PURPLE ATTACHMENT HAD BLACK SPECKS IDENTIFIED UPON OPENING THE OVERWRAP FROM 2 DIFFERENT LOTS. VERBATIM: THERE WERE ALSO A COUPLE OF NEEDLES THAT ON THE PURPLE ATTACHMENT HAD BLACK SPECKS IDENTIFIED UPON OPENING THE OVERWRAP FROM 2 DIFFERENT LOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650064 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED THAT THE BD® NEEDLE 1 1/2 IN. SINGLE USE, STERILE BROKE. THE FOLLOWING WAS TRANSLATED FROM SPANISH TO ENGLISH: I HEREBY INFORM THAT YESTERDAY, AUGUST 27, I WAS NOTIFIED THAT WHEN I WAS PREPARING MEDICATION, THE NEEDLE BROKE AND ONLY THE BASE REMAINED IN THE SYRINGE (EVIDENCE ATTACHED), IT IS WORTH MENTIONING THAT THE NURSE MENTIONED NOT HAVING APPLIED FORCE SINCE SHE WAS BARELY LOADING THE INJECTABLE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745673 ↗
• MalfunctionAug 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK SUBSTANCE FOUND IN 3 OF THE BD CONVENTIONAL NEEDLES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTS BLACK SUBSTANCE FOUND IN THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494846 ↗
• MalfunctionMay 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE NEEDLE WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 16G PRECISION GLIDE NEEDLE WITH HOLE AND DENT IN NEEDLE. DURING COMPOUNDING STERILE WATER LEAKED OUT OF NEEDLE DUE TO DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908589 ↗
• MalfunctionMar 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE, FOREIGN MATTER WAS FOUND ON THE BEVEL OF THE BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 16G 1 1/2 INCH BD PRECISION GLIDE NEEDLE HAS A WHITE PLASTER LIKE SUBSTANCE ON THE BEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657463 ↗
• MalfunctionMar 27, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE RUBBER STOPPER FORMS A CORE THAT REMAINS IN EITHER THE VIAL OR SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PIERCING DAPTOMYCIN VIAL WITH NEEDLE, RUBBER STOPPER FORMS A CORE THAT REMAINS IN EITHER THE VIAL OR SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624167 ↗
• MalfunctionMar 14, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE HYPODERMIC NEEDLE EXPERIENCED EPOXY ON NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHS ARE HAVING ISSUES WITH THE 16 GAUGE AND 18 GAUGE NEEDLES IN THE LAB. THERE SEEMS TO BE EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. THE GLUE IS OCCASIONALLY FLAKING OFF THE NEEDLE AND LANDING IN THE COMPOUNDING AREA. I DON'T HAVE A LOT OF INFO ABOUT LOT AND EXPIRATION. I WAS TOLD IT HAPPENS MORE WITH THE PURPLE 16 GAUGE NEEDLES THAN THE PINK 18 GAUGE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540706 ↗
• MalfunctionFeb 26, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE THERE WAS DAMAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXPERIENCED NEEDLE WITH A HOLE IN IT. WE ALSO RECENTLY RECEIVED A NEEDLE WITH WHOLE IN THE SHAFT. THANKS FOR YOUR ATTENTION TO THIS MATTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441359 ↗
• MalfunctionFeb 26, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE THERE WAS EPOXY ON THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL SETTING SERIAL COMPOUNDING WHITE GLUE BETWEEN THE HUB AND NEEDLE. WHITE FLAKES ARE EXPANDING AND BREAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441336 ↗
• MalfunctionJan 24, 2023Contamination; Contamination

  IT WAS REPORTED THAT EXCESSIVE EPOXY WAS FOUND ON THE BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OF NOTE NO PATIENTS RECEIVED ANY PRODUCT WITH USING THE CONTAMINATED NEEDLES. WE NOTICED THAT SOME NEEDLES ARE CONTAMINATED WITH GLUE LIKE MATERIAL"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237505 ↗

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