N/A 305156Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903051564), received between Feb 22, 2018 and Dec 11, 2023 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Leak/Splash; Leak/Splash

  (B)(4).ADDITIONAL INFORMATION RECEIVED (B)(6) 2023. ¿ PLEASE PROVIDE CORRECT MATERIAL AND LOT NUMBER. (PREVIOUSLY PROVIDE THE NUMBERS DOES NOT MATCH) THIS IS THE LOT NUMBER ON THE PATIENT KIT PROVIDED TO US. THE RECONSTITUTION NEEDLE WAS LOT 2117379 AND THE DOSING NEEDLE IS LOT 2263232 ¿ DATE OF EVENT: 17NOV2023. ¿ DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO ¿ HOW WAS TREATMENT COMPLETED FOR CUSTOMER? USED ANOTHER ¿ DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. NO .¿ PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NO. ¿ ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO. ¿ CAN YOU PLEASE PROVIDE MORE DETAILS AND DESCRIBE HOW THE PRODUCT IS DAMAGED. THE RECONSTITUTION LIQUID SQUIRTED OUTSIDE THE VIAL WHEN RECONSTITUTING. MATERIAL #: UNKNOWN. BATCH#: 2117379. IT WAS REPORTED BY CUSTOMER THAT WHEN CAREGIVER WAS INJECTING FLUID IN VIAL TO RECONSTITUTE, THE FLUID SQUIRTED OUTSIDE OF VIAL AND NOT INSIDE THE VIAL. VER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303150 ↗
• MalfunctionJun 29, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING HE BD MAXZERO¿ EXTENSION SET THAT THE LUERS (SCREW-ON HUB) ARE UNABLE TO LOOSEN TO ATTACH TO CATHETER HUB, AND ARE CAUSING LEAKING AT THE CONNECTION TO THE CATHETER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VERBATIM: LUER (SCREW-ON HUB) IS STICKING/UNABLE TO LOOSEN TO ATTACH TO CATHETER HUB, NOT LONG ENOUGH TO COVER INTERNAL EXTENSION, NOT SECURING PROPERLY AND IS CAUSING LEAKING AT THE CONNECTION TO THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 17224301 ↗
• MalfunctionJun 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE HAD A SUBSTANCE ON IT. THE FOLLOWING WAS RECIEVED FROM THE INITIAL REPORTER: VERBATIM: CUSTOMER OBSERVED A WHITISH SUBSTANCE ON A BD BRAND 22G 1½ INCH NEEDLE WHEN OPENING IT. I HAVE ATTACHED A PHOTO OF THE NEEDLE AND ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221824 ↗
• MalfunctionDec 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT REPORTING OVER THE YEARS SINCE HE¿S STARTED THERAPY THAT HE¿S HAD ISSUES WITH THE DILUENT SYRINGES INCLUDED IN THE GATTEX KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919537 ↗
• MalfunctionNov 22, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WILL NOT ALLOW YOU TO PUSH MEDS THROUGH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849702 ↗
• MalfunctionJul 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BD¿ NEEDLE 22X1-1/2 RB EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKED OUT OF THE SYRINGE WHERE THE NEEDLE WAS CONNECTED TO THE SYRINGE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033940 ↗
• MalfunctionApr 19, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED AND COULDN'T PUSH MEDICINE THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN TRYING TO INJECT PATIENTS JOINTS WITH MEDICATION USING THESE NEEDLES, THE MEDICATION WOULD NOT GO THROUGH. THE PROVIDER HAD TO TAKE THE NEEDLE OUT OF THE JOINT AND CHANGE THE NEEDLE TO FINISH THE INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14146387 ↗
• MalfunctionDec 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD NEEDLE 22X1-1/2 RB HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER THE ACCOUNT, THERE IS AN ISSUE WITH THE BD NEEDLES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921609 ↗
• MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NEEDLE 22X1-1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED: SPONTANEOUS: PATIENT REPORTS RECONSTITUTION SYRINGE LEAKING/FAILING OVER THE LAST FEW SHIPMENTS SHE HAS RECEIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351697 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT 2 NEEDLES 22X1-1/2 RB EXPERIENCED BROKEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: 9163867, 8361924.   IT WAS REPORTED THAT PR PACKAGE DIFFICULT TO OPEN RESULTED IN BROKEN INJECTION NEEDLES PR PACKAGE DIFFICULT TO OPEN - BROKEN INJECTION - NEEDLES ARE VERY HARD TO OPEN - PER PATIENT. DOSE IS 2.4 AND IT ONLY COULD SAVE W THESE BOTH TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809533 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THE BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY CAME OFF THE SYRINGE WHEN DRAWING UP MEDICATION DURING USE. THE NEEDLE ALSO CAME OFF WHEN INJECTING INTO THE SKIN, BUT NO DOSES WERE MISSED. LOT#'S 8331606 AND 9099872 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT REPORTED WHEN PREPARING THE MEDICATION THE NEEDLE IS PUSHED ON THE SYRINGE AND THEN USED TO DRAW UP THE MEDICATION. WHEN DRAWING UP THE MEDICATION THE NEEDLE WILL COME OFF. THE CALLER STATED THE PATIENT ALSO REPORTED THAT WHEN THE NEEDLE IS INJECTED INTO THE SKIN IT WILL COME OFF. THE CALLER CONFIRMED THERE ARE NO MISSED DOSES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759636 ↗
• MalfunctionFeb 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED BEFORE USE WITH A NEEDLE 22X1-1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE WAS NOT SECURELY CONNECTED TO THE SYRINGE WHICH CAUSE THE MEDICATION TO LEAK. AN INVESTIGATION FROM BECTON DICKINSON IS REQUIRED. BD LOT NUMBER(S): 8361924. PLEASE NOTE: THIS REPORT IS FOR LOOSE NEEDLE CONNECTION TO SWFI VIAL. WHICH NEEDLE IS THIS COMPLAINT REFERRING TO BELOW? NEEDLE. DID THIS COMPLAINT OCCUR IN OR OUTSIDE USA? IN USA . IS THE DATE OF EVENT KNOWN? (B)(6) 2020. WAS THERE ANY ADVERSE EVENTS DUE TO THE REPORTED ISSUE? MEDICAL INTERVENTION? COURSE OF TREATMENT CHANGE? OTHER ACTIONS? N/A. ARE ANY PATIENT IDENTIFIERS AVAILABLE? (I.E. GENDER, WEIGHT, ETHNICITY, ETC.) PATIENT IDENTIFIERS WILL NOT BE AVAILABLE FOR ANY INVESTIGATION REQUEST. WILL SAMPLES BE RETURNED FOR INVESTIGATION? SAMPLES OF DOSING SYRINGES AND NEEDLES CANNOT BE RETURNED FOR FURTHER EVALUATION. SAMPLES WERE DISCARDED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759602 ↗
• MalfunctionJan 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS EPOXY DISCOVERED ON NEEDLE PRIOR TO USE WITH A BD NEEDLE 22X1-1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS A WHITE SUBSTANCE ON THE NEEDLE PRIOR TO ANY MEDICATION BEING INJECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9640979 ↗
• MalfunctionAug 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY WAS CLOUDY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305156 BATCH NO. UNKNOWN (CUSTOMER PROVIDED 8172859 & 8090593) IT WAS REPORTED WHEN PATIENT DREW MEDICATION INTO THE SYRINGE IT TURNED CLOUDY. COMPLAINT DESCRIPTION: PT'S HUSBAND PREPARED GATTEX VIAL AS DIRECTED FOR INJECTION. EVERYTHING LOOKED NORMAL. AS HE WAS TRYING TO PULL UP THE MEDICINE INTO THE SYRINGE AS DIRECTED, THE SOLUTION TURNED CLOUDY. THIS HAD NEVER HAPPENED BEFORE. HE DISCARDED THE VIAL AND USED A NEW ONE AND EVERYTHING WAS FINE WITH THAT VIAL. NO ADVERSE EFFECTS NOTED. NO OTHER INFORMATION KNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895768 ↗
• MalfunctionJul 2, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE NEEDLE WAS CLOGGED AND UNABLE TO DRAW UP MEDICATION WITH A BD NEEDLE 22X1-1/2 RB. THIS OCCURRED ON 4 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE WAS UNABLE TO DRAW UP, NEEDLE CLOGGED/BLOCKED. PER ADDITIONAL INFORMATION PROVIDED: 7 BOXES ON OF PN#0723305156 LOT #8361924 AND THEY HAD TO PULL THE BOX THEY WERE NOT GETTING ANY FLOW INTO THE NEEDLE WHEN PULLING THE INJECTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8753342 ↗
• MalfunctionJul 1, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE W/O SAFETY WAS CLOGGED. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305156, BATCH NO. 8361924. IT WAS REPORTED THAT NEEDLE WAS UNABLE TO DRAW UP, NEEDLE CLOGGED/BLOCKED. PER EMAIL: ORDERED 7 BOXES AND THEY HAD TO PULL THE BOX THEY WERE NOT GETTING ANY FLOW INTO THE NEEDLE WHEN PULLING THE INJECTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8749483 ↗
• MalfunctionMar 12, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT BD NEEDLE ¿22X1-1/2 RB EXPERIENCED LEAKING WHILE USING THE SYRINGE. FROM EMAIL RESPONSE RECEIVED: 1. I DO NOT HAVE AN EXACT TOTAL FOR HOW MANY TIMES THIS HAPPENS. DR. 1 HAS TOLD ME THAT IT HAPPENS ALMOST EVERY DAY. HE HASN'T REPORTED IT TO ME EVERY TIME IT HAPPENS THOUGH. I'VE TOLD HIM SINCE OPENING UP A CASE WITH YOU, TO KEEP TRACK AND GATHER SAMPLES OF THE SYRINGES WHEN THIS HAPPENS. I HAVE ALSO ASKED DR. 2 (WHO HAS REPORTED TO ME THAT THIS HAPPENS TO HIM AS WELL) TO GATHER SAMPLE SYRINGES WHEN THIS OCCURS WITH HIM. 2. AGAIN, IT IS VERY DIFFICULT TO PROVIDE EXACT DATES OF OCCURRENCES AS THE DOCTORS HAVE NOT REPORTED TO ME EACH TIME THE LEAKING HAS HAPPENED. 3. DR. 1 DID START PROVIDING ME WITH SAMPLES ON MONDAY, FEBRUARY 25, 2019. I CURRENTLY HAVE 5-3CC SYRINGES WHERE THE LEAKING OCCURRED. 1-2/25/19. 2-2/27/19. 2-2/28/19. ----DR. 1 PRIMARILY USES 3CC LUER LOCK SAFETY SYRINGES FOR HIS CORTISONE INJECTIONS UNLESS HE IS PERFORMING AN ASPIRATION. DR. 2 PRIMARILY USES 10CC LUER LOCK SAFETY SYRINGES--I HAVE YET TO OBTAIN ANY SAMPLES OF 10CC SYRINGES. I AM HOPING TO PROVIDE YOU WITH A VARIETY. -WHEN DR. 1 PERFORMS A CORTISONE INJECTIONS HE USES 2-3CC SYRINGES, 1-18X

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8414309 ↗
• MalfunctionFeb 19, 2019Inaccurate Delivery

  IT WAS REPORTED THAT A NEEDLE 22X1-1/2 RB I IS NOT INJECTING FULL DOSE, AND LEAVES 0.5ML OF PRODUCT IN THE SYRINGE. THE PLUNGER STOPPER IN THE SYRINGE BARREL IS NOT FLUSH WITH THE BOTTOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351603 ↗
• MalfunctionFeb 18, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY HAD FOREIGN MATTER ON THE TIP OF THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8347826 ↗
• MalfunctionMar 20, 2018Component Missing; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE USE A BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY WAS FOUND WITH A STERILE BARRIER BREACH AS ¿THE TOP OF INJECTION PACKAGING BROKE.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7354017 ↗
• InjuryFeb 22, 2018Fail-Safe Problem; Protective Measures Problem

  IT WAS REPORTED THAT A NURSE PICKED UP A BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY AFTER IT WAS USED AND RECAPPED BY A PHYSICIAN DURING PROCEDURES. THE NEEDLE WAS PROTRUDING FROM THE SIDE OF THE CAP AND NURSE RECEIVED A DIRTY NEEDLE STICK. THERE WAS NO REPORT OR MEDICAL INTERVENTIONS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7289313 ↗

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