BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 20291397 · Received September 24, 2024

    Report

    Report Number
    1911916-2024-00694
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS PRECIPITATE IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. THERE IS A PARTICLE, 1/16" LONG AND LIGHT GRAY IN COLOR, LOCATED AT THE BOTTOM OF THE SYRINGE BARREL. THE THREE PHOTOS PROVIDED SHOW A SYRINGE WITH A PARTICLE IN A CLEAR SOLUTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS SENT TO A LABORATORY FOR ANALYSIS. THE SAMPLE WAS SENT TO A LABORATORY FOR ADDITIONAL ANALYSIS. THE RESULTS RETURNED INCONCLUSIVE WITH AN (B)(4) MATCH TO POLYETHYLENE, OR A TYPE OF PLASTIC. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4152396. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 302832; BATCH # 4152396. IT WAS REPORTED BY CUSTOMER THAT 30 ML SYRINGES THAT HAD PRECIPITATE IN THEM. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE USED A COUPLE OF 30 ML SYRINGES FOR 5FU THAT HAD PRECIPITATE IN THEM. SINCE 5FU CAN CRYSTALLIZE WHEN IT IS TOO COLD, WE ASSUMED THE ISSUE WAS THE DRUG. NOW WE HAVE HAD THE SAME TYPE OF SYRINGE WITH A DARZALEX FASPRO THAT HAD THE SAME TYPE OF DEBRIS. WE HAVE NEVER HAD AN ISSUE WITH THIS MEDICATION BEFORE. THE COMMON DENOMINATOR HERE IS THE 30 ML SYRINGE. IT IS NOT A CORING OF THE STOPPER SINCE WE USE BBRAUN ONGUARD ADAPTORS FOR COMPOUNDING. I HAVE TRIED TO REPEATEDLY OPEN A CASE VIA THE CUSTOMER PORTAL, BUT EVERYTHING IS GRAYED OUT. I HAVE REGISTERED FOR AN ACCOUNT AND IT JUST SENDS ME IN A NEVER ENDING LOOP. THE ITEM IN QUESTION IS: BD 30 ML SYRINGE LUER-LOK TIP; REF: 302832; LOT: 4152396; EXP: 05/31/2029.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT - NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870454 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4152396 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown