BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16660166 · Received March 31, 2023

    Report

    Report Number
    2243072-2023-00548
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON DICKINSON
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 24-MAR-2023. H.6. INVESTIGATION SUMMARY: 5 SAMPLES AND 2 PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO INSPECT THE RETURNED SAMPLES FOR THE REPORTED ISSUE OF LEAKAGE PAST STOPPER FROM LOT NUMBER 2243382 AND MATERIAL NUMBER 300850. THE INVESTIGATING TEAM HAS ALSO USED THE RETENTION SAMPLES OF LOT NUMBER 2243382 MATERIAL NUMBER 300850 FOR INVESTIGATING THE REPORTED DEFECT. THE DEVICE HISTORY REVIEW (DHR) OF MATERIAL NUMBER 300850 WITH LOT NUMBER 2243382 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NUMBER FROM ITS PRODUCTION DATE TO ITS DISPATCH DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON FOUR RETURNED SAMPLES & ONE RETENTION SAMPLE WHERE THE INVESTIGATING TEAM HAS FUNCTIONALLY TESTED THE SAMPLES FOR LEAKAGE. NO LEAKAGE OR CRACKED BARREL WAS FOUND. THE ORIGINAL CONTAMINATED SAMPLE WAS USED TO INVESTIGATE THE COMPLAINT OF BARREL CRACK AND LEAKAGE PAST STOPPER IT WAS FOUND THAT THE SAMPLE CONFIRMS THE DEFECT. AT BARREL PLUNGER ASSEMBLY, THERE IS A PLATE WHICH PROVIDES SUPPORT TO BARREL DURING PLUNGER INSERTION. GAP SETTING WAS DONE MANUALLY. AFTER MULTIPLE TRIALS IT WAS FOUND THAT AT 0.5MM OF GAP SETTING THERE IS NO LEAKAGE IN SYRINGE. A GAUGE FILLER WAS PROVIDED TO LINE OPERATOR TO ENSURE THAT 0.5MM OF GAP IS MAINTAINED WHILE ADJUSTING IT. AFTER THIS ADJUSTMENT, DURING IPQC LEAKAGE WAS CHECKED AND NO LEAKAGE WAS IDENTIFIED. ALL OPERATORS ARE TRAINED FOR THIS METHOD OF ADJUSTING GAP. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON FOUR RETURNED SAMPLE & ONE RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS FUNCTIONALLY TESTED THE SAMPLES FOR LEAKAGE AND NO LEAKAGE & NO CRACK BARREL WAS FOUND. THE ORIGINAL CONTAMINATED SAMPLE WAS USED TO INVESTIGATE THE COMPLAINT OF BARREL CRACK & LEAKAGE PAST IT WAS FOUND THAT THE SAMPLE SHOWS THE DEFECT OF BARREL CRACK & LEAKAGE PAST. SO, DEFECT IS CONFIRMED. AT BARREL PLUNGER ASSEMBLY, THERE IS A PLATE WHICH PROVIDES SUPPORT TO BARREL DURING PLUNGER INSERTION. GAP SETTING WAS DONE MANUALLY. AFTER MULTIPLE TRIALS IT WAS FOUND THAT AT 0.5MM OF GAP SETTING THERE IS NO LEAKAGE IN SYRINGE. A GAUGE FILLER WAS PROVIDED TO LINE OPERATOR TO ENSURE THAT 0.5MM OF GAP IS MAINTAINED WHILE ADJUSTING IT. AFTER THIS ADJUSTMENT, DURING IPQC LEAKAGE WAS CHECKED AND NO LEAKAGE WAS IDENTIFIED. ALL OPERATORS ARE TRAINED FOR THIS METHOD OF ADJUSTING GAP. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN MFR SITE AND FACILITY SITE AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 BD DISCARDIT¿ II SYRINGES LEAKED BLOOD PAST THE PLUNGER STOPPER DURING THE BLOOD DRAW. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO NOTICED BLOOD LEAKING INTO SYRINGE BARREL FROM THE SEAL WHEN BEING DRAWN DURING BLOOD COLLECTION. INCIDENT OCCURRED WITH MULTIPLE UNITS.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 BD DISCARDIT¿ II SYRINGES LEAKED BLOOD PAST THE PLUNGER STOPPER DURING THE BLOOD DRAW. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO NOTICED BLOOD LEAKING INTO SYRINGE BARREL FROM THE SEAL WHEN BEING DRAWN DURING BLOOD COLLECTION. INCIDENT OCCURRED WITH MULTIPLE UNITS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624457 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2243382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown