N/A 305145Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00382903051458), received between Feb 15, 2018 and Jan 27, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Contamination” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. VERBATIM: HARD WHITE SUBSTANCE ON OUTER SURFACE OF NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188964 ↗
• MalfunctionJan 9, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027267 ↗
• MalfunctionJan 9, 2026Contamination

  IT WAS REPORTED THAT BD NEEDLE 23X1 WAS CONTAMINATED WITH FOREIGN MATTER. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT DESCRIPTION: NEEDLE DISPOSABLE HSI ITEM NUMBER: 9870934. MANUFACTURER PART NUMBER: 305145. LOT OR SERIAL NUMBER: LOT NUMBER: EXPIRY DATE: 5064152, 04/30/2030. ISSUE: CLIENT REPORTS A "HARD, WHITE SUBSTANCE" ACCUMULATED ON OUTER SURFACE OF NEEDLES, IS RETICENT TO USE-- NO ADVERSE EVENT(S) REPORTED-- SF CASE (B)(4) RKEL01 12/15/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023644 ↗
• MalfunctionNov 1, 2024Contamination; Contamination

  MATERIAL#: 305145, BATCH#: 3347603. IT WAS REPORTED BY CUSTOMER THAT BLACK SPECKS FOUND IN NEEDLE PACKAGE. RCC RECEIVED A COMPLAINT VIA PHONE. REF: (B)(4), LOT: 3347603 (LOT WAS NOT SAVED FOR PREVIOUS NEEDLE IDENTIFIED WITH ISSUE), EVENT DATE: 10/29/2024, SAMPLE SAVED FOR INVESTIGATION. ISSUE: BLACK SPECKS FOUND IN NEEDLE PACKAGE, NOTICED THIS PRIOR WITH ANOTHER NEEDLE BUT DID NOT REPORT AT THE TIME. WOULD LIKE REPLACEMENTS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20590540 ↗
• MalfunctionNov 1, 2024Contamination; Contamination

  MATERIAL # 305145 . BATCH # 3347603 . IT WAS REPORTED BY CUSTOMER THAT BLACK SPECKS FOUND IN NEEDLE PACKAGE VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. XXX. YYY. REF: (B)(4). LOT: 3347603 (LOT WAS NOT SAVED FOR PREVIOUS NEEDLE IDENTIFIED WITH ISSUE). EVENT DATE: 10/29/2024. SAMPLE SAVED FOR INVESTIGATION. ISSUE: BLACK SPECKS FOUND IN NEEDLE PACKAGE, NOTICED THIS PRIOR WITH ANOTHER NEEDLE BUT DID NOT REPORT AT THE TIME. WOULD LIKE REPLACEMENTS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587410 ↗
• MalfunctionOct 23, 2023Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION RECEIVED MAT#: (B)(4) BATCH#: 2299263 IT WAS REPORTED BY CUSTOMER THAT THEY FOUND AN INCORRECT NEEDLE IN WITH THE 23GX1¿ PRECISION GLIDE NEEDLE. LOT: 2299263 EXP: 12-31-2027. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE FOUND AN INCORRECT NEEDLE IN WITH THE 23GX1¿ PRECISION GLIDE NEEDLE. LOT: 2299263 EXP: 12-31-2027 17OCT2023 ¿ DATE OF EVENT: (B)(6) 2023 ¿ EVENT WAS NOTED BEFORE USE ON PATIENT ¿ NO CHANGE OR DELAY IN TREATMENT ¿ PREPARING ANAPHYLAXIS KITS TO SEND TO THE HOME FOR PATIENTS ¿ YES SAMPLE IS AVAILABLE : XXX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984440 ↗
• MalfunctionJun 26, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH BD PRECISIONGLIDE¿ NEEDLES THE NEEDLE PULLED OUT OF HUB AND REMAINED IN PATIENT. PATIENT IMPACT WAS UNABLE TO BE OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT NEEDLE PART COMES OUT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205803 ↗
• MalfunctionMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE DISCONNECTED FROM THE HUB DURING THE CYSTOCENTESIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TODAY THE ACTUALLY NEEDLE DISCONNECTED FROM THE PLASTIC HUB DURING A CYSTOCENTESIS WHICH COULD HAVE CAUSED SERIOUS INJURY IF THE VA WAS NOT ABLE TO RETRIEVE THE NEEDLE PART WITH HER FINGERS FROM THE SKIN OF THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959311 ↗
• MalfunctionMay 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 4-5 BD PRECISIONGLIDE¿ NEEDLES WERE CLOGGED DURING THE INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD AN ISSUE WITH THE BD PRECISIONGLIDE NEEDLE... RANDOMLY THESE NEEDLES WILL NOT ALLOW FOR THE INJECTION TO GO THROUGH AND WILL APPEAR "CLOGGED"... 1. ARE YOU ABLE TO PROVIDE THE QUANTITY OF DEFECTIVE NEEDLES? IT IS RANDOM AND NOT ALL OF THE SAME LOT NUMBER ARE AFFECTED. HAS BEEN PROBABLY 4-5 NEEDLES PER DAY FOR THE PAST 2-3 WEEKS 2. WHAT WAS THE ANIMAL¿S OUTCOME? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NONE YET, TODAY THE ACTUALLY NEEDLE DISCONNECTED FROM THE PLASTIC HUB DURING A CYSTOCENTESIS WHICH COULD HAVE CAUSED SERIOUS INJURY IF THE VA WAS NOT ABLE TO RETRIEVE THE NEEDLE PART WITH HER FINGERS FROM THE SKIN OF THE PATIENT. 3. WAS THERE ANY VISIBLE BLOCKAGE? IF YES, KINDLY DESCRIBE. NO VISIBLE BLOCKAGE SEEN 4. WAS THIS NOTED ON THE FIRST USE? YES THEY ARE BRAND NEW NEEDLES FROM THE PACKAGING BEING USED FOR THE FIRST TIME WITH THESE OCCURRENCES. 5. WERE YOU ABLE TO DRAW UP SOLUTION AND THEN UNABLE TO EXPEL? NO, THE NEEDLES WERE CHANGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947337 ↗
• MalfunctionMar 9, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 IN. SINGLE USE, STERILE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WOULD NOT PRESS AIR THROUGH SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514708 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS USED AND THE PATIENT HAD AN INFECTION. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFECTION AFTER NEEDLE INJECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13904573 ↗
• InjuryJul 28, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT NEEDLE 23X1 RB PULLED OUT OF THE HUB AND BROKE. THE NEEDLE STUCK IN THE PATIENT AND THE PATIENT WENT TO THE EMERGENCY ROOM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER HAS A NEEDLE STUCK IN HIS BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 12236243 ↗
• MalfunctionMar 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NEEDLE 23X1 RB WAS "RUSTY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 OF THE NEEDLES IN THE BOX IS RUSTY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397204 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 8 NEEDLES 23X1 RB EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305145 BATCH NO.: 9057712. SYRINGES MISSING EXPIRATION DATE AND LOT NUMBERS MISSING NUMBERS/HARD TO READ.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9868320 ↗
• MalfunctionDec 3, 2018Material Separation

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE SEPARATED FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126677 ↗
• MalfunctionNov 21, 2018Device Slipped

  IT WAS REPORTED THAT A HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY HAD A CANNULA THAT WAS PULLED OUT OF HUB AND RELEASED INTO THE PATIENT'S SKIN DURING USE. THE CANNULA WAS PULLED FROM THE PATIENT WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096363 ↗
• MalfunctionApr 20, 2018Leak/Splash; Connection Problem

  IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ NEEDLE WOULD NOT SCREW TIGHTLY ON THE HUB WHICH RESULTED IN A MEDICATION SPILL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447114 ↗
• MalfunctionFeb 15, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USE OF THE BD PRECISIONGLIDE¿NEEDLE "THERE IS A CRUSTY WHITE COATING ON THE SYRINGE." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275378 ↗

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