N/A 301629Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382903016297), received between Mar 8, 2019 and Jun 2, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  DESCRIPTION: IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE STARTED LEAKING PART WAY UP THE HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MATERIAL: 301629. BATCH#: 2175224. WE WERE USING BD PRECISIONGLIDE NEEDLE 27G X 1 1.5, THE NEEDLE STARTED LEAKING PART WAY UP THE HUB. ADDITIONAL INFORMATION THE DATE OF THE EVENT WAS 5/21/25, UNABLE TO PROVIDE PHYSICAL SAMPLE AS IT WAS USED ON A PATIENT AND A DIRTY NEEDLE. WILL SEND PICTURE OF NEEDLE AND WHERE IT WAS LEAKING FROM CIRCLED IN BLACK (INCLUDED IN THIS EMAIL). NO ADVERSE EFFECTS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122488 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21505590 ↗
• InjuryFeb 26, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21469379 ↗
• MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash

  MATERIAL#: 301629, BATCH NUMBER#: 4033053. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED A PROVIDER HAD TO CHANGE OUT THE NEEDLE 4 TIMES WITH A RECENT PROCEDURE, REPORTING THAT WHEN SHE INJECTED THE MEDICATION, THE SOLUTION CAME OUT OF THE SIDES OF THE NEEDLE VS THE SHARP END WHERE THE HOLE IS AND SHOULD BE DELIVERED. PATIENT DIDN¿T RECEIVE THE MEDICATION AND A SECOND POKE HAD TO BE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421492 ↗
• MalfunctionNov 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED. BATCH 4050660.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639557 ↗
• MalfunctionSep 22, 2023Complete Blockage; Complete Blockage

  MAT#: UNKNOWN BATCH#: UNKNOWN; IT WAS REPORTED BY THE CUSTOMER THAT "SINCE OUR LAST COMMUNICATION, I HAVE FOUND TWO MORE PRECISION GLIDE NEEDLES WITH THE SAME CLOGGING ISSUE THAT I ORIGINALLY REPORTED". VERBATIM: SINCE OUR LAST COMMUNICATION, I HAVE FOUND TWO MORE PRECISION GLIDE NEEDLES WITH THE SAME CLOGGING ISSUE THAT I ORIGINALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799360 ↗
• MalfunctionSep 5, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD® NEEDLE 27 G X 1 1/2 IN. SINGLE USE, STERILE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WAS PERFORMING A TEST METHOD VALIDATION AND SAW AN ATYPICAL RESULT SUSPECTED TO BE FROM THE NEEDLE AS FURTHER INVESTIGATION SHOWED SIGNS OF AN OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686776 ↗
• InjuryAug 14, 2023Break; Break

  IT WAS REPORTED WHILE USING THE BD PRECISIONGLIDE¿ NEEDLE, THE NEEDLE FRACTURED AND BECAME LODGED INSIDE THE PATIENT¿S NECK. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: ON (B)(6) 2023, ONE OF CUSTOMER PHYSICIANS WAS PERFORMING A ROUTINE NERVE BLOCK PROCEDURE USING A 27GX1½ BD PRECISIONGLIDE NEEDLE. UNFORTUNATELY, DURING THE PROCEDURE, THE NEEDLE FRACTURED AND BECAME LODGED INSIDE THE PATIENT¿S NECK. THIS INCIDENT RESULTED IN COMPLICATIONS FOR THE PATIENT AND NECESSITATED IMMEDIATE MEDICAL ATTENTION AT A LOCAL HOSPITAL. CUSTOMER MEDICAL TEAM REACTED PROMPTLY TO ADDRESS THE SITUATION AND ENSURE THE PATIENT¿S SAFETY. ADD INFO RECEIVED ON 02-AUG-2023: 1ST CUSTOMER RESPONSE PHOTO EVIDENCE: ATTACHED ARE X-RAY IMAGES TAKEN WHEN THE NEEDLE WAS LODGED IN THE PATIENT'S NECK DURING A ROUTINE SPINAL ACCESSORY NERVE BLOCK INJECTION. PATIENT RECOVERY: THE PATIENT HAS RECOVERED. HOSPITAL REMOVED THE NEEDLE AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH NO COMPLICATIONS. HOW THE NEEDLE BROKE: THE NEEDLE BROKE AS DURING THE INJECTION, THE 27G 1.5 INCH NEEDLE SNAPPED AT THE HUB OF THE NEEDLE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE END OF THE NEEDLE WITH STERILE CLAMPS HOWEVER,

  Patient problems: Foreign Body In Patient

  MAUDE report 17546197 ↗
• MalfunctionJul 6, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD® NEEDLE 27 G X 1 1/2 IN. SINGLE USE, STERILE THERE WAS RESISTANCE. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: GIVING RESISTANCE WHEN MEDICATIONS ARE PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276162 ↗
• MalfunctionMay 1, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS FOUND CLOGGED DURING FORCE TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE PERFORMED BREAK-LOOSE GLIDE FORCE TESTING ON A SYRINGE WITH A BD PRECISIONGLIDE NEEDLE (27G 1.5") AND HAVE GENERATED DATA THAT GIVES US REASON TO BELIEVE THERE WAS AN OCCLUSION IN THE NEEDLE. IN THE SAME SAMPLE SET WE OBSERVED OTHER ATYPICAL FORCES THAT WE BELIEVE ARE INDICATIVE OF PARTIAL NEEDLE OCCLUSIONS. WE USED A PIN GAUGE TO DETERMINE IF THE NEEDLE WAS OCCLUDED AND FROM THE EVIDENCE WE GATHERED BELIEVE THE THERE IS A BLOCKAGE. THIS RESULT WAS NOT GENERATED ON WITH A NEEDLE INTENDED FOR HUMAN USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850243 ↗
• MalfunctionMar 8, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT 4 BOXES OF THE BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE, 27 G WERE ANOTHER PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ORDERED 17 CASES OF 301629 BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE, 27 G AND RECEIVED 13 OF THE CORRECT PRODUCT AND THE REMAINING 4 BOXES WAS ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16502914 ↗
• MalfunctionSep 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE 27GA 1-1/2IN HAD A HOLE IN THE NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED HUB BROKE OFF ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508768 ↗
• MalfunctionDec 30, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NEEDLE 27GA 1-1/2IN CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301629 BATCH NO.: 899538. IT WAS REPORTED THAT INCORRECT NEEDLE WAS IN SEALED PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 11095318 ↗
• MalfunctionOct 15, 2020Device Contamination with Chemical or Other Material; Material Twisted/Bent; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT 2 NEEDLES 27GA 1-1/2IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HAD A WHITE SUBSTANCE AND IS DISFIGURED. VERBATIM: CONSUMER REPORTED FOUND 2 NEEDLES WITH DISCOLORED/WHITE SUBSTANCE THAT IS DISFIGURED TOO. LOT # 8331594, CATALOG# 301629, DATE OF EVENT 09/18/2020 - DISCARD THIS 1 NEEDLE SAME ISSUE, DATE OF EVENT 09/22/2020 SENDING THIS SAMPLE BACK SAME ISSUE, SAMPLE STATUS AWAITING SAMPLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687588 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Material Twisted/Bent; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE 27GA 1-1/2IN WAS FOUND DEFORMED AND DISCOLORED WITH A WHITE SUBSTANCE ON IT BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 2 NEEDLES WITH DISCOLORED/WHITE SUBSTANCE THAT IS DISFIGURED TOO".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668527 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT A NEEDLE 27GA 1-1/2 IN BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN CUSTOMER'S NECK DURING PROCEDURE VERBATIM: DR. (B)(6) WAS PERFORMING A THYROID BIOPSY ON PATIENT WHEN THE NEEDLE BROKE OFF ON THE PATIENTS NECK. DR. (B)(6) STARTED THE PROCEDURE BY INSERTING THE NEEDLE INTO THE PATIENTS NECK. THIS TYPE OF BIOPSY IS ULTRA SOUND GUIDED. DR. (B)(6) STATES SHE STARTED MOVING THE NEEDLE TO COLLECT CELLS AND THINGS DIDN'T FEEL RIGHT. SHE STOPPED IMMEDIATELY AND FOUND THE NEEDLE WAS BROKEN. SHE HAD JUST A SMALL PIECE OF THE NEEDLE SHE COULD GRIP TO PULL THE NEEDLE OUT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182477 ↗
• MalfunctionApr 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NEEDLE 27GA 1-1/2IN HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301629 BATCH NO: 9030562. IT WAS REPORTED THAT EXPIRATION DATE ON THE PACKAGE OF THE NEEDLE IS DIFFERENT FROM THE EXPIRATION DATE ON THE COC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993355 ↗
• MalfunctionJul 26, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE NEEDLE 27GA 1-1/2IN EXPERIENCED AN INCORRECT EXPIRATION DATE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301629, BATCH NO. 9030562. COMPLAINT 2 OF 2. THE PACKING SLIP FOR ITEM 301629 LOT# 9030562 HAS AN EXPIRATION OF 02/29/2024 BUT THE BOX IS PRINTED WITH 6/29/2024. EMAIL 7/10/2019: THE CASE WAS FOUND ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833662 ↗
• MalfunctionJul 16, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE NEEDLE 27GA 1-1/2IN EXPERIENCED AN INCORRECT EXPIRATION DATE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301629 BATCH NO. 9030562. COMPLAINT 1 OF 2. EMAIL: THE PACKING SLIP FOR ITEM 301629 LOT# 9030562 HAS AN EXPIRATION OF 02/29/2024 BUT THE BOX IS PRINTED WITH 6/29/2024. EMAIL (B)(6) 2019. THIS CASE WAS FOUND IS: (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795323 ↗
• MalfunctionMar 8, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE 27GA 1-1/2IN THAT A WHITE SUBSTANCE WAS FOUND ON THE NEEDLE HUB.

  Patient problems: No Information

  MAUDE report 8403755 ↗

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