BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14304121 · Received May 6, 2022

    Report

    Report Number
    3002682307-2022-00134
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 9, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2012501. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FOR EVALUATION; HOWEVER, THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF DAMAGE. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN INLINE DETECTION SYSTEM WHICH INSPECTS ALL PRODUCT AN AUTOMATICALLY REJECTS ANY BROKEN PARTS IDENTIFIED. IT IS POSSIBLE THAT THE PRODUCT WAS DAMAGED DURING THE PRIMARY PACKAGING PROCESS DUE TO A CLOG IN THE SYRINGE FEEDER; HOWEVER, THIS CANNOT BE CONFIRMED WITH THE LIMITED INVESTIGATION RESULTS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF A BD DISCARDIT¿ II SYRINGE BROKE DURING USE WHICH CAUSED LEAKAGE AND BLOOD EXPOSURE. HOWEVER, NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHLEBOTOMIST WAS USING DISCARDIT 10ML SYRINGE FOR BLOOD COLLECTION AND BARREL OF THE SYRINGE WAS BROKEN WHILE COLLECTION. EXPOSURE TO BLOOD/BODILY FLUID? YES. ARE THE PATIENT AND PHLEBOTOMIST FINE? ANY ADVERSE EVENT CAUSED BY THE EXPOSURE? YES, BOTH ARE FINE AND THERE WAS NO ADVERSE EVENT CAUSED DUE TO EXPOSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF A BD DISCARDIT¿ II SYRINGE BROKE DURING USE WHICH CAUSED LEAKAGE AND BLOOD EXPOSURE. HOWEVER, NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHLEBOTOMIST WAS USING DISCARDIT 10ML SYRINGE FOR BLOOD COLLECTION AND BARREL OF THE SYRINGE WAS BROKEN WHILE COLLECTION. EXPOSURE TO BLOOD/BODILY FLUID? YES. ARE THE PATIENT AND PHLEBOTOMIST FINE? ANY ADVERSE EVENT CAUSED BY THE EXPOSURE? YES, BOTH ARE FINE AND THERE WAS NO ADVERSE EVENT CAUSED DUE TO EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206245 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown