BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9844911 · Received March 17, 2020

    Report

    Report Number
    1911916-2020-00265
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 13, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN¿T 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 36TH COMPLAINT FOR LOT # 8324761 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINTS 1484206, 1389598, 1387407, 1379571, 1379556, 1379341, 1368033, 1368018, 1368015, 1349090, 1337973, 1324614, 1323823, 1318531, 1259942, 1242031, 1239573, 1198795, 1186599, 1170580, 1159606, 1133137, 1131785, 1129592, 1114017, 1105806, 1098015, 1087908, 1069299, 1067242, 1007882, 1000465, 969946, 955528, 901446. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLES WERE CLOGGED WITH A BD PRECISIONGLIDE¿ NEEDLE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN USING 8324761 BATCHES OF INJECTION NEEDLES, THEY FOUND THAT 2 OF INJECTION NEEDLES WERE BLOCKED IN SUCCESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309325 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 8324761 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other