N/A 305110Recalls & reported problems

Summary

The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 00382903051106), received between Dec 6, 2017 and Jul 8, 2025 — classified as 6 injuries, 412 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (152 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 25 most recent of 418 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER, MEDICATION TO SPLASH OUT WHEN TRYING PULL OUT FOR ADMINISTRATION. PT'S (PATIENT'S) MOTHER REPORTED THE NEEDLES RECEIVED WERE BENT WHICH THEN CAUSED ALL THE MEDICATION TO SPLASH OUT WHEN TRYING PULL OUT FOR ADMINISTRATION. UNKNOWN IF PATIENT HAS MISSED DOSE. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT AS A RESULT. UNKNOWN IF PATIENT HAS DEFECTIVE PRODUCT ON HAND. UNKNOWN PRODUCT LOT NUMBER AND EXPIRATION DATE. ITEM#: 305110.

  Patient problems: Insufficient Information

  MAUDE report 22436367 ↗
• MalfunctionMar 28, 2025Connection Problem; Connection Problem

  MATERIAL #: 305110 BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT WHILE FILLING A NEW CARTRIDGE, THE NEEDLE CAME APART FROM THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ¿ CALLER REPORTED WHILE FILLING A NEW CARTRIDGE, THE NEEDLE CAME APART FROM THE SYRINGE. ¿ WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? ¿ ONE ¿ WAS THE SYRINGE/NEEDLE REUSED? - NO ¿ PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110. ¿ PRODUCT LOT # - UNAVAILABLE ¿ DID ISSUE CAUSE ANY INJURY? - NO ¿ HOW DID THE CALLER RESOLVE THE ISSUE? ¿ CHANGED SYRINGE AND NEEDLE AND SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. RESOLUTION ¿ NO FURTHER TANDEM FOLLOW UP IS REQUIRED. THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. NO CLOSURE LETTER IS REQUIRED FOR COMPLAINTS WHERE WE ARE NOT RETURNING SAMPLES FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719976 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677173 ↗
• MalfunctionJul 22, 2024Crack; Crack

  MATERIAL#: 305110. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT SYRINGE CRACKED AND INSULIN SPILLED OUT. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. 2) CALLER REPORTED [SYRINGE CRACKED AND INSULIN SPILLED OUT]. 3) WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? - [RECORD NUMBER]. 4) DID ALL ISSUES OCCUR ON THE SAME DAY? ¿ NO. ISSUES OCCURRED: [WITHIN PAST MONTH OR SO]. 5) WAS THE SYRINGE/NEEDLE REUSED? - NO. 6) PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110. 7) IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. 8) PRODUCT LOT # - UNAVAILABLE. 9) DID ISSUE CAUSE ANY INJURY? - NO. 11) HOW DID THE CUSTOMER RESOLVE THE ISSUE? ¿ CHANGED SYRINGE ONLY AND SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. RESOLUTION ¿ NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791743 ↗
• MalfunctionFeb 1, 2024Break; Break

  NEEDLE SNAPPED OFF SYRINGE WHEN TRYING TO FILL CARTRIDGE DISTRIBUTOR COMPLAINT REPORT - INTERNATIONAL DISTRIBUTOR INFORMATION DISTRIBUTOR NAME: AUSTRALASIAN MEDICAL & SCIENTIFIC LTD TANDEM DISTRIBUTOR ACCOUNT NUMBER: (B)(4). DISTRIBUTOR INCIDENT REFERENCE NUMBER: (B)(4). COUNTRY OF EVENT: AUSTRALIA DATE DISTRIBUTOR NOTIFIED: 20 JAN 2024 INCIDENT INFORMATION EVENT DATE: 19 JAN 2024 PRODUCT CATEGORY: NEEDLE ISSUE EVENT DETAILS (ATTACH ADDITIONAL PAGES IF NEEDED AND DO NOT INCLUDE THE PERSONAL DATA OF ANY INDIVIDUAL): 1) CALLER REPORTED NEEDLE SNAPPED OFF SYRINGE WHEN TRYING TO FILL CARTRIDGE 2) DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO3) WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? ¿ ONE 5) WAS THE SYRINGE/NEEDLE REUSED? - NO 6) PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110 7) IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO 8) PRODUCT LOT # - UNAVAILABLE 9) DID ISSUE CAUSE ANY INJURY? - NO 11) WAS CALLER ABLE TO FILL A CARTRIDGE WITH INSULIN? ¿ NO RESOLUTION ¿ REPLACED NEEDLE AND WAS ABLE TO FILL NEW ONE SEE ATTACHED FOR THE REST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621856 ↗
• MalfunctionDec 7, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282621 ↗
• MalfunctionNov 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIALS#: 305110 BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT CALLER REPORTED HAVING ISSUES REGARDING PIECES OF THE FILL PORT ENTERING THE SYRINGE CAUSING THE SYRINGE TO BE OBSCURED. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ¿ CALLER REPORTED HAVING ISSUES REGARDING PIECES OF THE FILL PORT ENTERING THE SYRINGE CAUSING THE SYRINGE TO BE OBSCURED. ¿ DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO ¿ WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? - [CALLER REPORTED AT LEAST 12] ¿ DID ALL ISSUES OCCUR ON THE SAME DAY? ¿ NO ISSUES OCCURRED: [WITHIN 2 MONTHS]. ¿ WAS THE SYRINGE/NEEDLE REUSED? - NO. ¿ PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110. ¿ IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. ¿ PRODUCT LOT # - UNAVAILABLE. ¿ DID ISSUE CAUSE ANY INJURY? - NO. ¿ RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. CREATED BY (B)(6) AT 10/23/2023 4:39:42 PM. SUBJECT: CTS NOTE SINCE CUSTOMER DID NOT REQUEST TO SPEAK TO SUPERVISOR NO FOLLOW UP IS NECESSARY. CTS TO SEND GOODWILL ORDER AND CLOSE CASE. CREATED BY (B)(6) AT 10/23/2023 4:24:05 PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209872 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD¿ NEEDLE THE NEEDLE BROKE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: DESCRIBE EVENT OR PROBLEM: CALLER REPORTED [NEEDLES BROKE DURING INSERTION INTO CARTRIDGE]. DID ISSUE CAUSE ANY INJURY? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730168 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD¿ NEEDLE THE NEEDLE BROKE. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: DESCRIBE EVENT OR PROBLEM: CALLER REPORTED [NEEDLES BROKE DURING INSERTION INTO CARTRIDGE ]. DID ISSUE CAUSE ANY INJURY? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730166 ↗
• MalfunctionJul 26, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE BROKE OFF AND INSULIN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY FILLED THE SYRINGE WITH INSULIN AND THEN THE NEEDLE BROKE OFF SOMEHOW AND CAUSED THE INSULIN TO COME OUT OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398214 ↗
• MalfunctionMay 1, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED THAT THE NEEDLE THAT THEY JUST UNPACKAGED AND OPENED IN THE SEALED PACKAGE LOOKED DIRTY AS IF IT HAD DRIED BLOOD ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849320 ↗
• MalfunctionApr 21, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED AFTER LOADING INSULIN INTO THE SYRINGE FROM THE INSULIN VIAL, CALLER NOTICED A SMALL OBJECT THAT RESEMBLES A ROCK FLOATING IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792348 ↗
• MalfunctionApr 10, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE CORED THE MEDICATION VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CALLER REPORTED FILL RESISTANCE ISSUE. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? -YES. WITH HOW MANY CARTRIDGES DID THE CALLER EXPERIENCE THE ISSUE? ¿ ONE. WAS THE SYRINGE/NEEDLE REUSED? - NO. WAS THE CARTRIDGE REUSED/REFILLED? - NO. 10) CUSTOMER'S BG AT TIME OF EVENT - [250 MG/DL] ; BETWEEN 54-500 MG/DL (3.0-27.7 MMOL/L). DOES INSULIN COME OUT OF THE EXISTING NEEDLE? - NO. WAS CALLER ABLE TO FILL THE EXISTING CARTRIDGE WITH THE SECOND NEEDLE? ¿ YES. RESOLUTION ¿ CALLER SUCCESSFULLY LOADED EXISTING CARTRIDGE WITH SECOND NEEDLE. ADDITIONAL INFO FROM PHONE CALL WITH CUSTOMER: CUSTOMER STATED THAT THEY FEEL STRONGLY THAT NEEDLE MIGHT BE CORING THE VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710506 ↗
• MalfunctionJan 20, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ NEEDLE 3/8 IN. SINGLE USE, STERILE, 26 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED REPORTED RESISTANCE GETTING THE NEEDLE INTO THE CARTRIDGE. CORRECTION: CALLER REPORTED THAT THEY COULD NOT PRESS DOWN ON THE PLUNGER OF THE SYRINGE DUE TO IT BEING STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219731 ↗
• MalfunctionDec 2, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED A CRACK BETWEEN THE PLASTIC AND THE NEEDLE AND INSULIN WAS COMING OUT OF THAT CRACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED THERE WAS A CRACK BETWEEN THE PLASTIC AND THE NEEDLE AND INSULIN WAS COMING OUT OF THAT CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902347 ↗
• MalfunctionNov 3, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISION GLIDE¿ NEEDLE EXPERIENCED LEAKAGE FROM DIFFICULTY CONNECTING TO MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED HAVING TROUBLE TWISTING NEEDLE ONTO SYRINGE. CALLER STATED THAT NEEDLE WAS UNABLE TO BE SCREWED ON COMPLETELY, LEAVING A GAP. AS A RESULT INSULIN SPRAYED OUT EACH TIME CONTACT ATTEMPT TO FILL SYRINGE/ CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721287 ↗
• MalfunctionOct 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED THAT WHEN HE ATTEMPTED TO FILL HIS CARTRIDGE WITH INSULIN HIS CARTRIDGE BEGAN TO LEAK. CUSTOMER REPORTED USING A NEW NEEDLE TO FILL CARTRIDGE. NUMBER OF OCCURRENCES - 1. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - 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 15619703 ↗
• MalfunctionSep 28, 2022Break; Break

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498819 ↗
• MalfunctionSep 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ONE BD PRECISIONGLIDE¿ NEEDLE HAD A FOREIGN PIECE OF PLASTIC ATTACHED TO THE END OF IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TODAY CUSTOMER SAW A SMILL PIECE OF PLASTIC ( AND NOT FROM WRAPPER) BUT SUTOMRT SAYS WHEN THET REMOVED NEEDLE FROM CRTRIDGE TO SHEE IF ISLUNE WHOULD COME OUT PUSHING PLUGER WITH NEEDLE NOT IN CARTRIDGE THEY NOTES THIS SMIL PIECE OF PLASTIC STUCK AND THE END OFF NEEDLE THAT WAS CAUSING BLOCKAGE CUSTOMER WAS ABLE TO REMOVE THAT SMALL PIECE OF PLASTICE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474789 ↗
• MalfunctionAug 16, 2022Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE SNAPPED IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234295 ↗
• MalfunctionAug 10, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE HAD WHITE DEBRIS IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED WHITE DEBRIS IN THE NEEDLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198964 ↗
• MalfunctionJul 26, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLES HAD BECOME CLOGGED OR KINKED CAUSING INSULIN TO FLOW IN OR OUT OF THE SYRINGE. THIS OCCURRED 3 TIMES THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLES BECOME CLOGGED OR KINKED CAUSING INSULIN TO FLOW IN OR OUT OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108327 ↗
• MalfunctionJul 26, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLES HAD FILL RESISTANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ENCOUNTERED A "FILL RESISTANCE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106959 ↗
• MalfunctionJul 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED SYRINGE LEAKING NUMBER OF OCCURRENCES - 2".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14923587 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT DURING USE THE BD LUER-LOK¿ 1-ML SYRINGE NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL#: 305110, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE BROKE OFF. VERBATIM: LOT: UNK: EXTERNALREF: (B)(4): CALLER REPORTED THE NEEDLE BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620099 ↗

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