BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL

    MDR report key: 11773607 · Received May 4, 2021

    Report

    Report Number
    1213809-2021-00291
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE LOOSE 1ML LUER LOCK SYRINGE WITH CUSTOMER ATTACHED TIP CAP WAS RECEIVED INSIDE OF A TRANSPARENT PLASTIC TRAY. THE SYRINGE WAS FILLED WITH AN UNKNOWN SUBSTANCE, THEREFORE A VISUAL EVALUATION THROUGH THE TRAY WAS PERFORMED. IT WAS OBSERVED THAT THE STOPPER APPEARED TO BE DEFORMED INSIDE THE BARREL, BUT STILL AFFIXED TO THE PLUNGER ROD. THE FIRST RIB OF THE STOPPER APPEARED TO BE MUCH LARGER THAN EXPECTED. THE PRECISE NATURE OF DEFORMITY WAS NOT CLEAR THROUGH THE PACKAGE. THE SAMPLE MUST BE DECONTAMINATED FOR A BETTER EVALUATION TO BE PERFORMED. DECONTAMINATION HAS BEEN PERFORMED. AFTER DECONTAMINATION THE SYRINGE WAS DISASSEMBLED. THE STOPPER WAS JAMMED WITHIN THE BARREL BOTTOM OUT POSITION AND WAS DIFFICULT TO REMOVE. SOME RESIDUAL MEDICINE REMAINED ON COMPONENTS. IT WAS DISCOVERED THAT THE STOPPER IN THIS SAMPLE HAD THE SAME HEIGHT BUT WAS MUCH LARGER IN ITS DIAMETER THAN THE STANDARD STOPPER FOR THIS PRODUCT. THE STOPPER WAS EVALUATED UNDER MAGNIFICATION. DUE TO MULTIPLE DISTORTIONS RESULTING FROM BEING JAMMED FOR A LONG TIME, THE MOLD AND/OR CAVITY NUMBERS COULD NOT BE READ ON THE STOPPER¿S SURFACE. POTENTIAL ROOT CAUSE FOR THE DISTORTED STOPPER DEFECT IS ASSOCIATED WITH INCORRECT MATERIAL FROM SUPPLIER. BASED ON THE EVIDENCE AVAILABLE TODAY, IT APPEARS AN INCORRECT STOPPER SIZE WAS RECEIVED MIXED IN WITH GOOD STOPPERS FROM THE STOPPER SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST WILL BE SENT TO THE STOPPER SUPPLIER. DUE DATE: JUL 1, 2021. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH, NO.: 9003930, UNKNOWN. IT WAS REPORTED THAT WHEN SYRINGE IS FILLED WITH TESTOSTERONE, RUBBER DEFORMS ALMOST LIKE DOUGH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 9003930, UNKNOWN. IT WAS REPORTED THAT WHEN SYRINGE IS FILLED WITH TESTOSTERONE, RUBBER DEFORMS ALMOST LIKE DOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667875 SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9003930 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1