N/A 305111Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00382903051113), received between Dec 7, 2018 and Jan 9, 2023 — classified as 1 injury, 61 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120255 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED WHEN USING THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CALLER REPORTED A NEEDLE BREAK. "THE NEEDLE WAS INSERTED INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE. CALLER SUCCESSFULLY LOADED EXISTING CARTRIDGE WITH SECOND NEEDLE. "THERE WAS NO HARM OR INJURY REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009666 ↗
• MalfunctionDec 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSULIN LEAKS OUT WHEN FILLING CART. CUSTOMER WAS ABLE TO FIL CART, BUT LOST INSULIN THROUGH LEAKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970583 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT 4 BD NEEDLE 26X1/2 RB BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED (4) NEEDLES THAT BROKE WHILE ATTEMPTING TO INSERT INTO THE CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968847 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED WHEN USING THE BD NEEDLE 26X1/2 RB, THE DEVICE EXPERIENCED A BROKEN NEEDLE. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CALLER REPORTED THAT TWO OF THE NEEDLES BROKE WHEN TRYING TO FILL THE CARTAGE WITH INSULIN. NUMBER OF OCCURRENCES - 2. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12905989 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED BD NEEDLE 26X1/2 RB HAD A NEEDLE BREAK ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED NEEDLE BROKE WHEN INSERTING IT INTO THE CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788099 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT THE NEEDLE 26X1/2 RB EXPERIENCED A BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED NEEDLE BROKE NUMBER OF OCCURRENCES 1 TIME. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550598 ↗
• MalfunctionSep 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB NEEDLE WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED FILL RESISTANCE. VERBATIM: (B)(4). CALLER REPORTED THAT NEEDLE WAS DEFECTIVE. NUMBER OF OCCURRENCES: 1 TIME. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. WAS THE SYRINGE/NEEDLE REUSED? NO. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? NO. RESOLUTION: CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER FOLLOW UP IS REQUIRED. CTS TO SEND REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537260 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB HAD A FILL RESISTANCE ISSUE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED FILL RESISTANCE ISSUE. CALLER REPORTED FILL RESISTANCE ISSUE. NUMBER OF OCCURRENCES - 2 TIMES DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - YES WAS THE SYRINGE/NEEDLE REUSED? - NO WAS THE CARTRIDGE REUSED/REFILLED? - NO PRODUCT WITH ISSUE CALLER DID NOT HAVE INFORMATION AT TIME OF THE CALL NEEDLE LOT # - UNAVAILABLE CUSTOMER'S BG AT TIME OF EVENT - 566MG/DL ; BETWEEN 54-500 MG/DL (3.0-27.7 MMOL/L), NO FURTHER BG QUESTIONS REQUIRED. DOES INSULIN COME OUT OF THE EXISTING NEEDLE? ¿ N/A, ISSUE HAPPENED IN THE PAST. CUSTOMER HAD ALREADY CHANGED NEEDLE [AND/] SYRINGE AT TIME OF CALL. WAS CALLER ABLE TO FILL THE EXISTING CARTRIDGE WITH THE SECOND NEEDLE? ¿ YES. RESOLUTION ¿ CALLER SUCCESSFULLY LOADED EXISTING CARTRIDGE WITH SECOND NEEDLE. CTS TO SEND GOODWILL ORDER OF CARTRIDGES TO REPLACE NEEDLE. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿CALLER DOES NOT HAVE THE SYRINGE/NEEDLE INFORMATION.

  Patient problems: Hyperglycemia

  MAUDE report 12464490 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE BROKE WHILE USING IT. CALLER REPORTED NEEDLE BROKE WHEN HE WAS ATTEMPT TO PULL AIR OUT OF THE CARTRIDGE. NUMBER OF OCCURRENCES - 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. WAS THE SYRINGE/NEEDLE REUSED? - NO. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER FOLLOW UP IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393157 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED NEEDLE 26X1/2 RB HAD BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HI THIS PATIENT HAS BROKEN A FEW SYRINGE NEEDLES TRYING TO FILL THE CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387994 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER NEEDLE BREAKING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346047 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB NEEDLE BROKE. THIS OCCURRED ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER NEEDLE BREAKING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346016 ↗
• MalfunctionAug 9, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED AND WOULDN'T ALLOW INSULIN TO FLOW THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED THAT INSULIN WOULD NOT GO THROUGH THE NEEDLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297880 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB BROKE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED FILL RESISTANCE AND IN ANOTHER INSTANCE THE NEEDLE BROKE WHILE ATTEMPTING TO DRAW INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264201 ↗
• MalfunctionJul 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED NEEDLE BENT WHEN TRYING TO INSERT INTO SECOND CARTRIDGE. NUMBER OF OCCURRENCES - 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. WAS THE SYRINGE/NEEDLE REUSED? - NO. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN, BUT NOT ALL OF INSULIN IN SYRINGE (SOME SPILLED OUT DUE TO BEND IN NEEDLE) CTS TO SEND REPLACEMENT CARTRIDGE AND NEEDLE/SYRINGE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249238 ↗
• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE OFF WHEN TRYING TO FILL THE CARTRIDGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED BREAKING A NEEDLE TRYING TO FILL HER CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010435 ↗
• MalfunctionJun 4, 2021Complete Blockage; Device Contamination with Chemical or Other Material; Complete Blockage; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5 NEEDLE 26X1/2 RB HAD CLOGGED NEEDLES AND FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CALLER REPORTED NEEDLES GETTING PLUGGED WITH WHITE RUBBER WHEN GETTING READY TO REFILL SYRINGE WITH INSULIN. TO RESOLVE ISSUE CALLER CHANGED NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936804 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE 16GX1-1/2IN RB BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CUSTOMER EXPERIENCED A BENT NEEDLE AND A BROKEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904963 ↗
• MalfunctionApr 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A NEEDLE 26X1/2 RB HAD A LOOSE NEEDLE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE WENT INTO THE SYRINGE WHEN PUSHING IT INTO THE CARTRIDGE, FILL RESISTANCE WAS ENCOUNTERED, EVENT DESCRIPTION PER ATTACHED EMAIL STATES: (B)(4). "CALLER REPORTED PATIENT STATES THE NEEDLE WENT INTO THE SYINGE WHEN NUMBER OF OCCURRENCES -1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. PRODUCT WITH ISSUE - BD 26 G, 1/2"" NEEDLE, PN 305111. PRODUCT LOT # - UNAVAILABLE. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. WAS CALLER ABLE TO FILL A CARTRIDGE WITH INSULIN? ¿ NO. RESOLUTION ¿ PATIENT CHANGE SYRINGES AND WAS ABLE TO FILL CARTRIDGE. CREATED BY (CUSTOMER) AT 3/22/2021 6:41:23 PM. SUBJECT: CTS NOTE. CTS TO CLARIFY SYRINGE INTAKE NOTE. CALLER REPORTED THE NEEDLE WENT INTO THE SYRINGE WHEN PUSHING IT INTO THE CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701756 ↗
• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE IN THE CARTRIDGE WHEN THE CONSUMER EXERTED "TOO MUCH FORCE" ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED INSERTING SYRINGE NEEDLE INTO CARTRIDGE, CUSTOMER USED TO MUCH FORCE AND BROKE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449501 ↗
• MalfunctionFeb 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB HAD STAINS IN THE CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111, BATCH NO: 9193541. IT WAS REPORTED STAINS IN THE CAPS. VERBATIM: PER CUSTOMER'S E-MAIL SENT TO US ON (B)(6) 2021. WHAT IS THE DATE OF EVENT? THE ITEMS WERE IDENTIFIED ON (B)(6) 2021. WAS ANYONE HURT? NOT AT THIS MOMENT, THIS WAS IDENTIFIED IN THE PRODUCTION LINE DO YOU HAVE PATIENT IDENTIFIERS? NOT APPLICABLE, IDENTIFIED IN THE PRODUCTION LINE. HOW MANY NEEDLES WERE WITH STAINS? THE CUSTOMER SORTED 1000 UNITS AND FOUND 220 WITH ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 11270171 ↗
• MalfunctionFeb 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE 26X1/2 RB HAD STAINS IN THE CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111, BATCH NO: 9193541. IT WAS REPORTED STAINS IN THE CAPS. VERBATIM: PER CUSTOMER'S E-MAIL SENT TO US ON (B)(6) 2021. WHAT IS THE DATE OF EVENT? THE ITEMS WERE IDENTIFIED ON (B)(6) 2021. WAS ANYONE HURT? NOT AT THIS MOMENT, THIS WAS IDENTIFIED IN THE PRODUCTION LINE. DO YOU HAVE PATIENT IDENTIFIERS? NOT APPLICABLE, IDENTIFIED IN THE PRODUCTION LINE. HOW MANY NEEDLES WERE WITH STAINS? THE CUSTOMER SORTED 1000 UNITS AND FOUND 220 WITH ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 11270079 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED A NEEDLE THAT BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED NEEDLES ARE BENDING WHEN INSERTING INTO CARTRIDGE (5) AND (1) NEEDLE BROKE OFF INTO CARTRIDGE. CUSTOMER STATED THAT THIS HAS BEEN AN ISSUE SINCE STARTING ON THE PUMP. EVENT DATE IS ESTIMATED AT DATE AFTER PUMP SHIP DATE. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PRODUCT WITH ISSUE - BD 26 G, 1/2" NEEDLE, PN 305111. PRODUCT LOT # UNAVAILABLE. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860805 ↗
• MalfunctionNov 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED [NEEDLE DID NOT NOT FIT ON TO SYRINGE AND LEAKED INSULIN WHEN FILLING CARTRIDGE]. NUMBER OF OCCURRENCES: [1]. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PRODUCT WITH ISSUE: BD 26 G, 1/2" NEEDLE, PN 305111. PRODUCT LOT #: UNAVAILABLE. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860766 ↗

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