BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 10242554 · Received July 7, 2020

    Report

    Report Number
    1911916-2020-00625
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 16, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED; THEREFORE, A SAMPLE ANALYSIS CAN¿T BE PERFORMED, AND THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. THERE'S NO REPORTED ISSUES DURING PRODUCTION AND INSPECTION OF THIS LOT. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 0031367 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE TO BE ANALYZED THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED; ANYWAY, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THIS LOT WAS PRODUCED FOR 0.179MM UNITS; THEREFORE, THE CPM IS 5.5; WE WILL CONTINUE MONITORING THIS PRODUCT AND LOT. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE TO BE ANALYZED THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 30ML LL S/C 56 CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A SMALL PIECE OF PLASTIC IN THE SYRINGE BARREL STUCK TO THE PLUNGER. ISSUE: SMALL WHITE PIECE OF PLASTIC POSSIBLY LODGED IN THE SYRINGE BARREL STUCK TO PLUNGER. ONCE PLUNGER REMOVED ABLE TO PULL OFF SMALL WHITE PIECE OF PLASTIC(?)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707261 SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0031367 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other