BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ESWAB COLLECTION KIT, FLEXIBLE MINITIP

    MDR report key: 11901377 · Received May 28, 2021

    Report

    Report Number
    1119779-2021-00911
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    October 2, 2020
    Report Date
    November 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO SERVES TO SUMMARIZE FINDINGS ON PRODUCT 220532 (SWAB COLLECTION KIT FLEXIBLE MINI), LOT NUMBER UNKNOWN, WHERE IT WAS OBSERVED THAT THE SWAB SHAFT WAS EXPELLED FROM THE TUBE. " AFTER PERFORMING COVID TEST, PIN PUT IN TUBE, BENDING PIN AT THE ... BY LEANING ON THE EDGE OF THE TUBE AND AT THE MOMENT OF BREAKING, THE PART LOCATED IN THE TUBE COMES OUT AND IS EXPELLED FROM THE TUBE AND TOUCHES THE FACE OF THE NURSE BEFORE FALLING ON THE FLOOR.¿ A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED AS A BATCH NUMBER WASN'T PROVIDED. NO PHOTOS OR RETURNS WERE AVAILABLE. AN INSPECTION OF THE RETENTION SAMPLES CANNOT BE COMPLETED AS NO BATCH NUMBER WAS GIVEN. BASED ON THE INVESTIGATION, THIS COMPLAINT CANNOT BE CONFIRMED FOR A DEFECT. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING. BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SAMPLING PATIENT FOR COVID WITH A BD¿ ESWAB COLLECTION KIT, FLEXIBLE MINITIP TUBE BROKE AND LIQUID SPLASHED ON NURSES FACE. NURSE WAS SENT TO HEALTH CARE FACILITY FOR DISINFECTION. PATIENT WILL BE RE-SAMPLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AFTER PERFORMING COVID TEST, PIN PUT IN TUBE, BENDING PIN AT THE ... BY LEANING ON THE EDGE OF THE TUBE AND AT THE MOMENT OF BREAKING, THE PART LOCATED IN THE TUBE COMES OUT AND IS EXPELLED FROM THE TUBE AND TOUCHES THE FACE OF THE NURSE BEFORE FALLING ON THE FLOOR. HANDLING REDONE AT "...", IN FACT THE SAMPLING PIN COMPRESSED IN THE TUBE COMES OUT AND IS EXPELLED FROM THE TUBE. CURRENT STATE OF THE PATIENT : - RISK OF CONTAMINATION FOR THE MEDICAL STAFF - COVID SAMPLING TO BE REDONE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SAMPLING PATIENT FOR COVID WITH A BD¿ ESWAB COLLECTION KIT, FLEXIBLE MINITIP TUBE BROKE AND LIQUID SPLASHED ON NURSES FACE. NURSE WAS SENT TO HEALTH CARE FACILITY FOR DISINFECTION. PATIENT WILL BE RE-SAMPLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER PERFORMING COVID TEST, PIN PUT IN TUBE, BENDING PIN AT THE ... BY LEANING ON THE EDGE OF THE TUBE AND AT THE MOMENT OF BREAKING, THE PART LOCATED IN THE TUBE COMES OUT AND IS EXPELLED FROM THE TUBE AND TOUCHES THE FACE OF THE NURSE BEFORE FALLING ON THE FLOOR. HANDLING REDONE AT "...", IN FACT THE SAMPLING PIN COMPRESSED IN THE TUBE COMES OUT AND IS EXPELLED FROM THE TUBE. CURRENT STATE OF THE PATIENT: RISK OF CONTAMINATION FOR THE MEDICAL STAFF - COVID SAMPLING TO BE REDONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798890 BD¿ ESWAB COLLECTION KIT, FLEXIBLE MINITIP SYSTEM, TRANSPORT, ANAEROBIC JTW BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other