N/A 305175Recalls & reported problems
Becton, Dickinson And Company · NEEDLE 20GA 1IN · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903051755), received between Oct 9, 2020 and Feb 20, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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/Splash2
- Complete Blockage1
- Delivered as Unsterile Product1
Patient problems
- No Consequences Or Impact To Patient2
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #:305175. BATCH#:2056681. IT WAS REPORTED BY CUSTOMER THAT THE CLINICAL ANESTHESIA TEAM RECENTLY FOUND BLOCKED HYPO BD NEEDLES. VERBATIM: "NOUS AVONS REÇU UNE RÉCLAMATION POUR LES ARTICLES BD 305175 ET 305106, L¿ÉQUIPE CLINIQUE D¿ANESTHÉSIE A RÉCEMMENT TROUVÉ DES AIGUILLES HYPO BD BLOQUÉES. " "POUR L'ARTICLE # 305175, ON N'EST PAS CERTAIN CAR L'EMBALLAGE A ÉTÉ JETÉ, MAIS IL SE PEUT QUI SOIT UN DE CES LOTS: 2056681, 21117190 OU 20209321". "WE HAVE RECEIVED A COMPLAINT FOR BD 305175 AND 305106 ITEMS, THE CLINICAL ANESTHESIA TEAM RECENTLY FOUND BLOCKED HYPO BD NEEDLES." "FOR ITEM # 305175, WE ARE NOT SURE BECAUSE THE PACKAGING HAS BEEN DISCARDED, BUT IT MAY BE ONE OF THESE LOTS: 2056681, 21117190 OR 20209321". ADDITIONAL INFORMATION: 1. VEUILLEZ NOUS INDIQUER LA DATE OÙ L¿INCIDENT S¿EST PRODUIT. VEUILLEZ CONFIRMER SI LES NUMÉROS DE LOT SONT 21117190 ET 20209321, ET S¿ILS SONT TOUCHÉS ? EITHER ONE WAS A POSSIBILITY. MOST REPORTED INCIDENT: (B)(6) 2024. THE PACKAGING WAS DISCARDED, BUT UPON VERIFICATION OF THE BD NEEDLES IN THE OR, THE LOT NUMBER COULD BE NARROWED DOWN TO 2 -LOT: 2020931 OR 2056681. 2. ÊTES-VOUS EN MESURE DE NOUS FOURNIR UN É
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739004 ↗MalfunctionAug 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE NEEDLE 20GA 1IN PIERCED THROUGH THE SHIELD BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PHARMACY TECHNICIAN EXPERIENCED A NEEDLESTICK INJURY WHEN RECAPPING A NEEDLE IN OUR STERILE COMPOUNDING ROOM. THE NEEDLE CAME THROUGH THE SIDE OF THE NEEDLE TIP COVER."
Patient problems: Needle Stick/Puncture
MAUDE report 12263201 ↗MalfunctionOct 15, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT NEEDLE 20GA 1IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT. PER ATTACHED FOLLOW UP RESPONSE: FOR 1835952. INCIDENT DATE? (B)(6) 2020 AND (B)(6) 2020. WHAT MEDICATION WAS BEING DRAWN UP? ON (B)(6)- PEVNAR23 AND ON (B)(6)- PREVNAR13. IS PRODUCT AVAILABLE TO RETURN FOR INVESTIGATION? THIS SPECIFIC PRODUCT WAS THROWN AWAY BUT HAVE UNUSED PRODUCTS THAT CAN BE SENT. EVENT DESCRIPTION STATES: THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. THE PRODUCTS THAT WERE USED, PRODUCT # AND LOT # ARE BELOW: BD 3ML SYRINGE WITH LUER-LOK TIP PRODUCT # 9870248 LOT # 0122550, BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550 LOT # 8324804. PLEASE SEE THE 3 FORMS FOR MORE INFORMATION. ANY INFORMATION REGARDING WHETHER THIS IS A PRODUCT ISSUE OR USER ERROR WOULD BE APPRECIATED. EVENT DETAILS STATES: IN SEPARATE INSTANCE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10687999 ↗MalfunctionOct 9, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE NEEDLE 20GA 1IN EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 5 THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550, LOT # 8324804. IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10659134 ↗
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
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.