BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 14394952 · Received May 13, 2022

    Report

    Report Number
    1911916-2022-00257
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 26, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051960
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED ? : THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5108531. INVESTIGATION SUMMARY : EXEC SUMMARY - NO PHYSICAL DEVICE SAMPLES WERE RETURNED. AS NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED, THE INVESTIGATION AND REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED AND BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT OR CONDITION OF FOREIGN MATTER WITH LOT #1120195. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR BATCH # 1120195 WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER IN THE FLUID PATH ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PATIENT NOTED DEBRIS IN A BD PRECISIONGLIDE NEEDLE 18G X 1 ½ INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382408 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1120195 00382903051960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown