BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 10312291 · Received July 23, 2020

    Report

    Report Number
    1911916-2020-00670
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 9, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: THREE PHOTOS WERE PROVIDED AND EVALUATED. THE FIRST PHOTO SHOWS A PUMP. 2ND PHOTO SHOWS A SYRINGE IN ITS SEALED PACKAGING BLISTER, AND THE 3RD PHOTO SHOWS THE PACKAGING BLISTER TOP WEB CONFIRMING THE PRODUCT AND LOT#. SAMPLES WOULD HAVE TO BE SENT TO CORPORATE R&D TO BE TESTED IN A SIMILAR PUMP. THERE IS NO RECORD FOR A SIMILAR SYMPTOM REPORTED TO THIS PRODUCT. ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION AND SAMPLE ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER COULDN¿T BE CONFIRMED. 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. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 0008597 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 AND SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULDN¿T BE CONFIRMED. THIS IS THE 1ST COMPLAINT FOR EACH OF THE LOT#S REPORTED. EACH LOT WAS PRODUCED FOR 0.134MM UNITS; EACH HAS A CPM OF 7.4; WE WILL CONTINUE MONITORING THIS LOT AND PRODUCT. ROOT CAUSE DESCRIPTION: THIS IS THE 1ST COMPLAINT FOR THIS TYPE OF SYMPTOM. SAMPLES WOULD HAVE TO BE SENT TO CORPORATE R&D TO BE TESTED IN A SIMILAR PUMP. THERE IS NO RECORD FOR SIMILAR SYMPTOM REPORTED TO THIS PRODUCT; THEREFORE A PROBABLE ROOT CAUSE CAN¿T BE OFFERED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 30ML LL S/C 56 EXPERIENCED ERRONEOUS RESULTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302832 BATCH NO: 0008597. ISSUE: CONTINUOUS KETAMINE INFUSIONS (30ML SYRINGE) VIA PCA PUMP - MACHINE KEEPS ON BEEPING "OCCLUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782114 SYRINGE 30ML LL S/C 56 SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0008597 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other