N/A 305165Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 21X1 RB · Class 2
Quick summary
This is a BD PrecisionGlide hypodermic needle with a regular bevel. The 28 adverse event reports mostly describe needles leaking or spraying liquid from the hub or base, needles puncturing through their own shield, and dark specks or foreign material found inside the needle before or during use. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382903051656), received between Jan 25, 2019 and Apr 3, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (11 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash11
- Material Puncture/Hole7
- Device Contamination with Chemical or Other Material5
- Defective Component3
- Break2
- Contamination2
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information2
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Contamination
IT WAS REPORTED BY CUSTOMER THAT BLACK SPECKS INSIDE THE NEEDLE COVERS. ADDITIONAL INFORMATION: BLACK SPECS ALMOST LOOK LIKE MOLD UNSURE OF EXACT SUBSTANCE. INSIDE PLASTIC/WRAPPED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776494 ↗MalfunctionMar 9, 2026Contamination
IT WAS REPORTED BY CUSTOMER THAT FOREIGN MATTER IN THE NEEDLE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545741 ↗MalfunctionJan 13, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063079 ↗MalfunctionOct 16, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BD NEEDLE 21X1 RB WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305165, BATCH#: 4212463. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT: (B)(4), PRODUCT: BD 21G X 1" NEEDLE 100/BOX, PRODUCT#: 15-5165-4, LOT#: 4212463. COMPLAINT: A PERITONEAL DIALYSIS (PD) REGISTER NURSE (CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT A COMPLAINT REGARDING THE PRODUCT BD 21G X 1" NEEDLE 100/BOX. SHE STATED THAT THE NEEDLE WAS BENT OUT OF THE PLASTIC SAFETY PLACE AND A STAFF MEMBER WAS POKED WITH THE NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23312577 ↗MalfunctionAug 26, 2025Leak/Splash; Leak/Splash
IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: MATERIAL: 305165; BATCH: 4354369. ITEM LEAKED WHEN PATIENT PRESSED DOWN TO GIVE INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22896916 ↗MalfunctionApr 25, 2025Leak/Splash; Leak/Splash
MATERIAL #305165, LOT #3347656. IT WAS REPORTED BY CUSTOMER THAT LEAK AT THE BASE PLASTIC END OF THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. AS PER ACCOUNT, I WANTED TO REPORT A DEFECT WITH ITEM PRODUCT NUMBER 308-305165 (21G 1IN NEEDLE ONLY). THERE WAS A SIGNIFICANT LEAK AT THE BASE PLASTIC END OF THE NEEDLE. PLEASE SEND A REPLACEMENT FOR THIS ITEM AND INFORM XXXX CANADA INC OF DEFECT. ADDITIONAL INFORMATION: THE EXACT DATE THE EVENT OCCURRED WAS 15 APR 2025. I DO HAVE THE DEFECTIVE PRODUCT IN MY POSITION AND AM ABLE TO RETURN IT. YOU CAN SHIP THE RETURN LABEL TO (B)(6) OR EMAIL IT TO ME, AND WE CAN PUT IT IN AN ENVELOPE WITH THE LABEL TO SHIP OUT. THERE WAS NO HARM TO THE PATIENT OR CAREGIVER. THE DEFECT WAS NOTICED WHILE TRYING TO RECONSTITUTE MEDICATION, AND THERE WAS ONLY SALINE DRAWN INTO THE SYRINGE AT THE TIME (SO NO LOSS OF MEDICATION). OUR NURSE NOTICED THE DEFECT, BAGGED IT FOR ME, AND USED A NEW ONE TO CONTINUE RECONSTITUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909693 ↗MalfunctionMay 6, 2024Break; Break
MATERIAL # 305165 LOT # 2056673 IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN ISSUE WITH A 21 G BD PRECISIONGLIDE NEEDLE. WHILE USING THIS NEEDLE AND A 3ML LUER LOCK BD SYRINGE TO TRANSFER CONTENTS OF VIAL 1 TO VIAL 2 IN A PHARMACEUTICAL PREP THEY NOTICED A SMALL SPRAY OF LIQUID COMING OUT FROM THE HUB OF THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. TODAY WE HAD AN ISSUE WITH A 21 G BD PRECISIONGLIDE NEEDLE. WHILE USING THIS NEEDLE AND A 3ML LUER LOCK BD SYRINGE TO TRANSFER CONTENTS OF VIAL 1 TO VIAL 2 IN A PHARMACEUTICAL PREP WE NOTICED A SMALL SPRAY OF LIQUID COMING OUT FROM THE HUB OF THE NEEDLE. WE REPEATED THE MOTION OF INJECTING LIQUID INTO A VIAL AND SAW THE SPRAY AGAIN. PRODUCT: BD PRECISION GLIDE NEEDLE 21G X 1 (0.8MM X 25 MM) REF (B)(4) LOT 2056673.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249669 ↗MalfunctionMar 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 305165 BATCH#: 3334855 IT WAS REPORTED BY THE CUSTOMER THAT ONE OF OUR PHARMACISTS IDENTIFIED A NEEDLE WITH SEVERAL DARK SPOTS ON IT. IT IS STILL SEALED SO I CAN NOT TELL EXACTLY WHERE IT IS IN THE PACKAGING. VERBATIM: ONE OF OUR PHARMACISTS IDENTIFIED A NEEDLE WITH SEVERAL DARK SPOTS ON IT. IT IS STILL SEALED SO I CAN NOT TELL EXACTLY WHERE IT IS IN THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004606 ↗MalfunctionMar 19, 2024Defective Component; Defective Component
MATERIAL: 305165. BATCH#: 3299612. IT WAS REPORTED BY THE 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: 305165. LOT NUMBER(S): 3299612. 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 18934662 ↗MalfunctionDec 4, 2023Defective Component; Defective Component
PR 9279082 ADDITIONAL INFORMATION: MATERIAL#: 305165 , BATCH#: 3179250. IT WAS REPORTED BY CUSTOMER THAT SOME THE BD NEEDLES ARE HAVING CORING ISSUES AND ALSO NOTICED THAT LOT NO. 3179250 APPEARS SLIGHTLY LONGER WITH A LONGER BEVEL (LIGHTER GREEN NEEDLE HUB) THAN THAT OF LOT NO. 2228051 (DARKER GREEN NEEDLE HUB). VERBATIM: REGARDING ONE OF MY CUSTOMER¿S HAVING A ¿CORING¿ ISSUE WITH SOME OF YOUR BD NEEDLES. TEAM BD PLEASE SEE COMPLAINT BELOW REGARDING ONE OF MY CUSTOMER¿S HAVING A ¿CORING¿ ISSUE WITH SOME OF YOUR BD NEEDLES. LOT #: 3179250. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 29-NOV-2023. 1) WHAT IS THE EVENT OCCURRENCE DATE? 10/22/2023. 2) WHAT WAS THE PATIENT IMPACT? NO PATIENT IMPACT. THE CORED VIALS WERE SEPARATED FROM THE BATCH. 3) IS THE SAMPLE AVAILABLE TO SEND BACK FOR EVALUATION? IF YES, PLEASE PROVIDE SHIPPING ADDRESS FOR SENDING RETURN LABEL FROM (B)(6). 4) PLEASE PROVIDE MATERIAL NUMBER. I AM NOT SURE WHERE TO LOCATE THE MATERIAL NUMBER. I HAVE ATTACHED A PICTURE OF THE BACK OF THE NEEDLE BELOW. 5) PLEASE CONFIRM LOT NUMBER. THE LOT NUMBER PROVIDED 3179250 WAS NOT FOUND IN OUR RECORDS. 3179250 APPEARS TO BE THE LOT NU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255271 ↗MalfunctionNov 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305165, BATCH #: 2299299, 3055942. IT WAS REPORTED BY CUSTOMER THAT THERE WAS BURRING AND PARTICULATES ALONG THE LENGTH OF THE NEEDLE. VERBATIM: "WE RECENTLY BOUGHT 10 CASES OF PART BD-305165: NEEDLE BD SINGLE USE 21G X 1" GREEN. WE RECEIVED 7 CASES OF LOT 2299299 AND 3 CASES OF 3055942. DURING TESTING THE LAB WAS SEEING ABNORMAL NEEDLE PERFORMANCE. UPON FURTHER INTERNAL INVESTIGATION IT WAS NOTICED THERE WAS BURRING AND PARTICULATES ALONG THE LENGTH OF THE NEEDLE. THEREFORE, THESE ARE UNUSABLE. WE RECEIVED LOT 2228051 IN A PRIOR DELIVERY, AND THEY ARE WORKING AS EXPECTED. I WAS WONDERING IF IT WAS POSSIBLE TO GET MORE CASES OF LOT 2228051 OR A COMPLETELY NEW LOT DELIVERED?"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18181970 ↗MalfunctionSep 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD® NEEDLE 1 IN. SINGLE USE, STERILE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED A BLACK SPEC WAS NOTICED IN THE HUB OF THE 21 G NEEDLE (305165).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17799640 ↗MalfunctionSep 6, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD® NEEDLE 1 IN. SINGLE USE, STERILE LEAKED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: HOWEVER, ON AUGUST 21, I WAS CONTACTED AT AROUND 9:20 A.M. TO REPORT A RADIOACTIVE SPILL FOLLOWING A NEEDLE LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695310 ↗MalfunctionSep 1, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS A LEAK WHILE USING THE BD PRECISIONGLIDE¿ NEEDLES. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INTIIAL REPORTER: PROBLEM: ON 2 OCCASIONS (MID-JULY AND AUGUST 1), THE NEEDLE, WHEN MOUNTED ON A SYRINGE, LEAKS ON THE SIDE OF THE CANNULA. THERE SEEMS TO BE A SMALL LEAK. AS WE'RE DEALING WITH RADIOACTIVE PRODUCTS, THERE'S A RISK OF CONTAMINATION OF WORK AREAS, OR SPLASHES ON A PATIENT OR EMPLOYEE. THE PROBLEMATIC NEEDLES HAVE NOT BEEN PRESERVED, BUT WE HAVE TWO SAMPLES OF THE PROBLEMATIC BATCH.
Patient problems: Insufficient Information
MAUDE report 17668850 ↗MalfunctionSep 1, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS A LEAK WHILE USING THE BD PRECISIONGLIDE¿ NEEDLES. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PROBLEM: ON 2 OCCASIONS ((B)(6)), THE NEEDLE, WHEN MOUNTED ON A SYRINGE, LEAKS ON THE SIDE OF THE CANNULA. THERE SEEMS TO BE A SMALL LEAK. AS WE'RE DEALING WITH RADIOACTIVE PRODUCTS, THERE'S A RISK OF CONTAMINATION OF WORK AREAS, OR SPLASHES ON A PATIENT OR EMPLOYEE. THE PROBLEMATIC NEEDLES HAVE NOT BEEN PRESERVED, BUT WE HAVE TWO SAMPLES OF THE PROBLEMATIC BATCH.
Patient problems: Insufficient Information
MAUDE report 17668846 ↗MalfunctionJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD® NEEDLE 1 IN. SINGLE USE, STERILE, 21 G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE IS A HOLE AT THE BASE OF THE NEEDLE WHICH LEAKS WHEN PREPARING THE MEDICATION. A NURSE RECEIVED SOME IN HER GLASSES, BECAUSE THERE WAS A SPURT THAT WAS PROJECTED WHEN SHE GAVE THE INJECTION. ADDITIONAL INFO RECEIVED ON 04-JULY-23. 1. WAS THE NURSE INJURED? PLEASE DESCRIBE. NO HARM RELATED TO THE CURRENT INCIDENT, AS THE NURSE WAS WEARING GLASSES, FORTUNATELY. SHE RECEIVED A JET IN HER GLASSES. SHE WAS DOING AN IV DRUG DILUTION. 2. WAS THE PATIENT INJURED? NO HARM TO THE PATIENT ACCORDING TO THE INCIDENT NOTED. HOWEVER, A NUMBER OF PEOPLE HAVE MENTIONED LEAKS IN THE JUNCTION BETWEEN THE SYRINGE AND THE NEEDLE. IF LITTLE RESISTANCE IS MADE, THERE IS NO JET COMING OUT, BUT MORE LEAKS. COULD CREATE IMPROPER MEDICATION PREPARATION, INCORRECT CONCENTRATION. 3. WAS THERE ANY MEDICAL INTERVENTION? NO MEDICAL INTERVENTION PERFORMED ON THE PATIENT. 4. COULD THE PROCEDURE BE CORRECTED USING ANOTHER NEEDLE? YES THE PROCEDURE COULD BE CORRECTED USING ANOTHER NEEDLE, BUT IT TOOK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17421333 ↗MalfunctionJul 12, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED THAT DURING MEDICATION PREPARATION WITH 2 BD 21G 1IN NEEDLE A HOLE WAS DISCOVERED AT THE BASE OF THE NEEDLE AND LEAKAGE OCCURRED. MEDICATION SPRAYED INTO NURSES GLASSES, THERE WAS NO ADDITIONAL IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE IS A HOLE AT THE BASE OF THE NEEDLE WHICH LEAKS WHEN PREPARING THE MEDICATION. A NURSE RECEIVED SOME IN HER GLASSES, BECAUSE THERE WAS A SPURT THAT WAS PROJECTED WHEN SHE GAVE THE INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17312988 ↗MalfunctionApr 24, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ 21 G X 1 IN. THERE WAS A HOLE IN THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT HAD A HOLE IN THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16804451 ↗MalfunctionMar 24, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE CAUSED MEDICATION TO LEAK OUT WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT HOLES ON SIDE OF THE NEEDLE HUB THAT CAUSE LEAKAGE WHEN DRAWING MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16610518 ↗MalfunctionJan 30, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT HOLES IN THE BD PRECISIONGLIDE¿ NEEDLE HUB CAUSED MEDICATION TO LEAK OUT WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF HAVE NOTED WHAT THEY FEEL TO BE ¿DEFECTIVENESS¿ RELATED TO THE BD PRECISION GLIDE NEEDLES 21GX1¿ (CONCORDANCE ITEM #113936) LOT 2244944. FEW AND FAR BETWEEN, BUT HAVE BEEN NOTICING HOLES IN THE SIDE OF THE NEEDLE HUB WHICH CAUSES MEDICATIONS TO LEAK OUT DURING DRAW UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16269581 ↗MalfunctionJan 30, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED HOLES IN THE SIDE OF THE NEEDLE HUB CAUSING THE MEDICATION TO LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FEW AND FAR BETWEEN BUT HAVE BEEN NOTICING HOLES IN THE SIDE OF THE NEEDLE HUB WHICH CAUSES MEDICATIONS TO LEAK OUT DURING DRAW UP.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16265145 ↗MalfunctionJan 25, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT A HOLE IN THE HUB OF THE BD PRECISIONGLIDE¿ NEEDLE CAUSED MEDICATION TO LEAK OUT WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF HAVE NOTED WHAT THEY FEEL TO BE ¿DEFECTIVENESS¿ RELATED TO THE BD PRECISION GLIDE NEEDLES. FEW AND FAR BETWEEN, BUT HAVE BEEN NOTICING HOLES IN THE SIDE OF THE NEEDLE HUB WHICH CAUSES MEDICATIONS TO LEAK OUT DURING DRAW UP".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16244531 ↗MalfunctionJul 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CONSUMER LEAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950835 ↗MalfunctionMay 27, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS DEFECTIVE WITH HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD HOLES IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14527280 ↗MalfunctionMay 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 21 G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER LEAKAGE. EVENT DATE: (B)(6) 2022. MEDICATION IS SQUIRTING OUT AT THIS SPOT. THEY HAVE HAD OVER TEN FAILURES IN THE PAST WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14338183 ↗
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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.