N/A 300912Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 00382903009121), received between Oct 25, 2017 and Jul 9, 2026 — classified as 1 injury, 176 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (42 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); 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 177 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Volume Accuracy Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765527 ↗
• MalfunctionApr 24, 2026Obstruction of Flow

  IT WAS REPORTED THAT BD SYRINGE 10ML LL EUROGRAPHICS HAD PUMP INCOMPATIBILITY. COMMERCIAL REFERENCE: (B)(4) LOT NUMBER: 5287155 DATE OF OCCURRENCE: 30/03/2026. DESCRIPTION OF INCIDENT: IT WAS REPORTED THAT THE NURSE TRIED TO INJECT MEDICATION INTO A CENTRAL LINE USING A 10ML SYRINGE CONNECTED TO AN ELECTRIC SYRINGE PUMP. THE SYRINGE PUMP WAS QUICKLY OCCLUDED. THIS IS A RECURRING PROBLEM. NO PROBLEM WITH 20ML SYRINGES. CONSEQUENCES: LOSS OF TIME FOR THE NURSES AND RISK OF INFECTION DUE TO INCREASED HANDLING ON ONE APPROACH. ACTION TAKEN: CHANGE SYRINGE TO 20ML THE DEVICE IS NOT AVAILABLE FOR EXPERT APPRAISAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987100 ↗
• MalfunctionMar 18, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632027 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL EUROGRAPHICS CONTAINED VISIBLE SILICONE. VERBATIM: LUBRICANT VISIBLE IN THE SYRINGE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393311 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL EUROGRAPHICS CONTAINED VISIBLE SILICONE. VERBATIM: LUBRICANT VISIBLE IN THE SYRINGE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393305 ↗
• MalfunctionFeb 19, 2026Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393302 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL EUROGRAPHICS CONTAINED VISIBLE SILICONE. VERBATIM: LUBRICANT VISIBLE IN THE SYRINGE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393294 ↗
• MalfunctionDec 18, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838609 ↗
• MalfunctionDec 18, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838608 ↗
• MalfunctionDec 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THEY WOULD LIKE TO ENQUIRE (POSSIBLY REPEATEDLY) ABOUT THE LUBRICANT RESIDUES IN THE SYRINGE RESERVOIR. THIS WAS PARTICULARLY NOTICEABLE IN THE 10 ML SYRINGES, AS THE PLUNGER IN THE CURRENT LOT IS PUSHED ALL THE WAY TO THE END (WITHOUT A GAP OF 1-2 ML). DURING INITIAL USE, IT WAS NOTICED THAT LIQUID REMAINS IN THE SYRINGE NEAR THE SYRINGE OUTLET. WE DETERMINED THAT THIS LIQUID IS THE LUBRICANT. WE WOULD LIKE TO KNOW WHETHER THE LUBRICANT IS HARMLESS TO HUMANS AND, ABOVE ALL, WHETHER IT HAS ANY EFFECT ON THE PREPARATIONS DRAWN UP WITH THE SYRINGE. WE PRIMARILY USE CARRIER SOLUTIONS SUCH AS ISOTONIC NACL AND 5% GLUCOSE SOLUTIONS, AS WELL AS MANY DIFFERENT CYTOSTATIC DRUGS AND ANTIBODIES. ADDITIONAL INFORMATION PROVIDED: IN ORDER FOR US TO FULLY INVESTIGATE YOUR COMPLAINT AND PROVIDE YOU WITH THE MOST DETAILED RESULTS POSSIBLE, WE ASK THAT YOU ANSWER THE FOLLOWING QUESTIONS: WAS THE DEVICE BEING USED IN/ON THE PATIENT WHEN THE PROBLEM OCCURRED? NO. WAS THE PATIENT OR USER HARMED? IF SO, PLEASE EXPLAIN NO SPECIFIC REPORT TO DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752540 ↗
• MalfunctionNov 18, 2025Short Fill; Short Fill

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581956 ↗
• MalfunctionNov 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON B)(6) 2025, A PARTICLE IS OBSERVED IN THE 10 ML SYRINGE. THE DEFECT ITEM IS NOT AVAILABLE. HOWEVER, THE PICTURE SHOWING THE DEFECT IS PROVIDED IN THE ATTACHMENT TO SUPPORT INVESTIGATION. A ROOT CAUSE WITHIN NOVARTIS CAN BE NEARLY BE EXCLUDED. WE KINDLY ASK YOU TO INVESTIGATE THE ROOT CAUSE AND SEND YOUR INVESTIGATION REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577150 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075633 ↗
• MalfunctionAug 22, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE HAD AN ISSUE WITH VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BRAUN SYRINGE PUMP DOES NOT EMPTY THE ENTIRE SYRINGE OF MEDICINE WHEN THE BRAUN SYRINGE PUMP ALARMS THAT THE INFUSION (DOSE IN THE SYRINGE) HAS BEEN ADMINISTERED, IT TURNS OUT THAT 0.7-0.8 ML IS MISSING FROM THE SYRINGE. IT MUST BE ADMINISTERED AT A SPECIFIC AND CONSISTENT SPEED. IT MUST ALSO BE ADMINISTERED BY PUMP BECAUSE ELEVATED PRESSURE CAN BE MONITORED DURING ADMINISTRATION. WE HAD TO RESET THE PUMP SEVERAL TIMES SO THAT MORE OF THE MEDICINE COULD BE ADMINISTERED, BUT EVENTUALLY THE PUMP INDICATED THAT THE ARM HAD REACHED ITS END POSITION. AT THIS POINT, THERE WAS STILL 0.45 ML LEFT IN THE PUMP. THEY ARE CALLED BD PLASTIC PACKS. THEY ARE MANUFACTURED IN THE USA AND AROUND EUROPE. THE SYRINGES HAVE SLIGHT DIFFERENCES DEPENDING ON WHERE THEY WERE MANUFACTURED, WHICH IS WHY THIS HAPPENS. WE TRIED A BRAUN 10 ML SYRINGE AND DID NOT ENCOUNTER THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22875943 ↗
• MalfunctionAug 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A MEDICATION WAS TO BE ADMINISTERED TO A PATIENT. HOWEVER, CONTAMINATION WAS FOUND ON THE SYRINGE PLUNGER BEFORE USE. THEREFORE, THIS SYRINGE WAS NOT USED BUT WAS KEPT AS A SAMPLE AND KINDLY MADE AVAILABLE TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865659 ↗
• MalfunctionAug 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? DURING USE "AFTER CONNECTING THE SYRINGE TO THE PUMP, A LEAK STARTED FROM THE SYRINGE BODY. THE SYRINGE CONTAINED TPN." ADDITIONAL INFORMATION PROVIDED: ¿ IS THE PUMP CONNECTED TO THE PATIENT = YES ¿ WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN = NO ¿ WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? = YES ¿ IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED= TPN ¿ WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN ¿ NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857086 ↗
• MalfunctionAug 19, 2025Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846338 ↗
• MalfunctionAug 1, 2025Leak/Splash; Leak/Splash

  SAMPLE RECEIVED IS A 20 ML SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687479 ↗
• MalfunctionMay 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A CUSTOMER COMPLAINT REGARDING THE PIECE OF PAPER IN BD 10 ML SYRINGE 3303135 LOT PRODUCT WE SENT TO OUR CUSTOMER FOR 300912 SKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113387 ↗
• MalfunctionMay 29, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD A VOLUMETRIC ACCURACY PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NAME: SER 3P VERROU 10 ML, CATALOGUE NUMBER: 300912, LOT NUMBER: 5006307, DATE OF OCCURRENCE: (B)(6) 2025. DESCRIPTION OF THE FACTS: THE VOLUMES TAKEN WITH THE 10ML LL BD SYRINGES REF 300912 ARE INCORRECT. BY WITHDRAWING 10ML WITH THIS MODEL OF SYRINGE, THIS CORRESPONDS TO 9.7ML CONTRARY TO OTHER SYRINGES (IN PARTICULAR THE 10ML BD NON-LL SYRINGES, REF 307736, BATCH 2501119). CLINICAL CONSEQUENCES OBSERVED: RISK OF UNDER DOSING IN INJECTABLE CHEMOTHERAPY PREPARATIONS USING 10 ML SYRINGES. DEVICE AVAILABLE FOR EXPERT APPRAISAL: YES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110841 ↗
• MalfunctionApr 18, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL NEUROGRAPHIC PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: REF : MV25-47. PLEASE FIND ENCLOSED A MATERIAL SAFETY REPORT SENT TO ANSM, CONCERNING A 10 ML LUER LOK BD SYRINGE, REFERENCE (B)(4), LOT NUMBER 4347922. THE DEVICE IS BEING HELD AT THE PHARMACY PENDING YOUR RETURN CONDITIONS. DESCRIPTION OF FACTS: " WHEN RETURNING BLOOD TO AN IMPLANTABLE CHAMBER, THE PLUNGER DETACHES FROM THE SYRINGE. RISK FOR THE PATIENT OF AN AIR BUBBLE (RISK OF EMBOLISM)¿. ADDITIONAL INFORMATION PROVIDED: RESPONSE RECEIVED: HAS THE PATIENT OR USER SUFFERED ANY HARM? NO, BUT RISK OF EMBOLISM WE'VE BEEN TOLD THAT SAMPLES ARE AVAILABLE FOR INVESTIGATION. COULD YOU PLEASE SPECIFY WHETHER THE SAMPLES ARE. USED (DURING OR AFTER USE) WITH SALINE SOLUTION. IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. WE SEND THE DEVICE TO OUR LOGISTICS PLATFORM. ONE OF MY COLLEAGUES WILL CONTACT YOU TO ARRANGE THE RETURN OF THE DEVICE. I REMAIN AT YOUR DISPOSAL IF NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869603 ↗
• MalfunctionFeb 26, 2025Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21474626 ↗
• MalfunctionFeb 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SYRINGE 10ML LL EUROGRAPHICS HAD LABEL CONTENT MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: 14 10ML LL SYRINGES, REFERENCE 300912, HAVE BEEN RETURNED TO US BECAUSE THE LOT NUMBER AND EXPIRATION DATE WERE MISSING FROM THE PACKAGING (SEE ATTACHED PHOTO). RETURN ADDRESS FOR RETAINED SAMPLES: (B)(6). ADDITIONAL INFORMATION PROVIDED: CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? YES, IF YES, PLEASE SPECIFY WHETHER THE SAMPLES ARE UNUSED (BEFORE USE): UNUSED USED (DURING OR AFTER USE) IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. IF YOU HAVE RETAINED A SAMPLE FOR INVESTIGATION, PLEASE PROVIDE US WITH THE COLLECTION ADDRESS (FULL DETAILS - PLEASE USE THE TEMPLATE BELOW). TO ENSURE EASY COLLECTION, WE STRONGLY RECOMMEND THAT YOU PROVIDE AN EASILY ACCESSIBLE LOCATION, SUCH AS THE HOSPITAL PHARMACY, YOUR GOODS IN/OUT DEPARTMENT, MAILROOM OR MAIN RECEPTION. THE ADDRESS SHOULD NOT BE INSIDE THE HOSPITAL UNIT (MATERNITY, ONCOLOGY, ETC.). (B)(6). PLEASE ALSO PROVIDE US WITH THE TELEPHONE NUMBER OF A PERSON WHO CAN BE CONTACTED BY THE CARR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414749 ↗
• MalfunctionJan 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208161 ↗
• MalfunctionDec 26, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: PACKAGING INSUFFICIENTLY SEALED OR NON-STERILE, PACKAGING CAN BE OPENED TOO EASILY (LOW RESISTANCE). WHEN DID THE INCIDENT OCCUR? BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023268 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4