BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 19625403 · Received June 27, 2024

    Report

    Report Number
    1911916-2024-00456
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 26, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS AN UNKNOWN GRAYISH STICKY SUBSTANCE ON THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THERE IS A PARTICLE, 3/16" IN SIZE, ATTACHED TO THE OUTER SIDE OF THE SYRINGE BARREL UNDER THE BARREL FLANGE. THE PARTICLE IS A MIX OF THE LUBRICANT APPLIED TO THE SYRINGE AND DUST. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, AFTER MAINTENANCE OR EQUIPMENT REPAIR OF THE SILICONE APPLICATION PROCESS, RESIDUES OF SILICONE WAS LEFT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4030281. 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. VERIFICATION OF THE SILICONE APPLICATION PROCESS WAS PERFORMED. NO RESIDUES OF SILICONE OR ANY OTHER FOREIGN MATTER WAS OBSERVED. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED: MATERIAL#: 302832, BATCH NUMBER#: 4030281. IT WAS REPORTED BY CUSTOMER THAT WHEN A PHARMACY TECHNICIAN TOOK THE SYRINGE OUT AND BEGAN DRAWING UP MEDICATION TO BE INJECTED, THE PHARMACY TECHNICIAN NOTICED THAT ON THE PLUNGER OF THE SYRINGE AND ON THE OUTSIDE BARREL AROUND THE BARREL FLANGE, THERE WAS SOME UNKNOWN GRAYISH STICKY SUBSTANCE. AS THE MEDICATION WAS DRAWN UP, THE TECHNICIAN DID NOT FEEL COMFORTABLE TRANSFERRING THE MEDICATION TO ANOTHER SYRINGE TO BE USED BECAUSE THEY THOUGHT IT ALREADY CONTAMINATED THE MEDICATION. THEREFORE, THE MEDICATION WAS WASTED. VERBATIM#: RCC RECEIVED A COMPLAINT VIA PHONE. REF: 302832, LOT: 4030281. ISSUE: WHEN A PHARMACY TECHNICIAN TOOK THE SYRINGE OUT AND BEGAN DRAWING UP MEDICATION TO BE INJECTED, THE PHARMACY TECHNICIAN NOTICED THAT ON THE PLUNGER OF THE SYRINGE AND ON THE OUTSIDE BARREL AROUND THE BARREL FLANGE, THERE WAS SOME UNKNOWN GRAYISH STICKY SUBSTANCE. AS THE MEDICATION WAS DRAWN UP, THE TECHNICIAN DID NOT FEEL COMFORTABLE TRANSFERRING THE MEDICATION TO ANOTHER SYRINGE TO BE USED BECAUSE THEY THOUGHT IT ALREADY CONTAMINATED THE MEDICATION. THEREFORE THE MEDICATION WAS WASTED. PT HARM: DID NOT REACH DATE OF EVENT: 6/26/2024. SAMPLE AVAILABLE: YES.

    Description of Event or Problem · 0

    MATERIAL#: 302832, BATCH NUMBER#: 4030281. IT WAS REPORTED BY CUSTOMER THAT WHEN A PHARMACY TECHNICIAN TOOK THE SYRINGE OUT AND BEGAN DRAWING UP MEDICATION TO BE INJECTED, THE PHARMACY TECHNICIAN NOTICED THAT ON THE PLUNGER OF THE SYRINGE AND ON THE OUTSIDE BARREL AROUND THE BARREL FLANGE, THERE WAS SOME UNKNOWN GRAYISH STICKY SUBSTANCE. AS THE MEDICATION WAS DRAWN UP, THE TECHNICIAN DID NOT FEEL COMFORTABLE TRANSFERRING THE MEDICATION TO ANOTHER SYRINGE TO BE USED BECAUSE THEY THOUGHT IT ALREADY CONTAMINATED THE MEDICATION. THEREFORE, THE MEDICATION WAS WASTED. VERBATIM#: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF: 302832. LOT: 4030281. ISSUE: WHEN A PHARMACY TECHNICIAN TOOK THE SYRINGE OUT AND BEGAN DRAWING UP MEDICATION TO BE INJECTED, THE PHARMACY TECHNICIAN NOTICED THAT ON THE PLUNGER OF THE SYRINGE AND ON THE OUTSIDE BARREL AROUND THE BARREL FLANGE, THERE WAS SOME UNKNOWN GRAYISH STICKY SUBSTANCE. AS THE MEDICATION WAS DRAWN UP, THE TECHNICIAN DID NOT FEEL COMFORTABLE TRANSFERRING THE MEDICATION TO ANOTHER SYRINGE TO BE USED BECAUSE THEY THOUGHT IT ALREADY CONTAMINATED THE MEDICATION. THEREFORE THE MEDICATION WAS WASTED. PT HARM: DID NOT REACH. DATE OF EVENT: 6/26/24. SAMPLE AVAILABLE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698699 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4030281 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown