BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II 2 ML WITH 25G X 1

    MDR report key: 12215672 · Received July 22, 2021

    Report

    Report Number
    2243072-2021-01956
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 28, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-26. H6: INVESTIGATION SUMMARY: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES (16) DISCARDIT 2ML, FROM LOT # 0214097, ITEM # 301866 WITH THE REPORTED ISSUE OF ¿SYRINGES RECEIVED WITH DAMAGED SYRINGE¿. THE DHR OF MATERIAL NUMBER 301866 AND LOT NUMBER 0214097 WAS CHECKED FOR ANY QUALITY NOTIFICATION AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. (PLEASE NOTE THAT THE PIR FORM MENTIONED 0214907 WHILE THE CORRECT BATCH THAT WAS SUPPLIED TO THE CUSTOMER AND THE SAMPLES RECEIVED ARE OF 0214097). SIXTEEN SAMPLES WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECTS. THE INVESTIGATING TEAM ALSO USED THE RETENTION SAMPLES OF MATERIAL CODE 301866 AND LOT NUMBER 0214097 FOR INVESTIGATING THE REPORTED DEFECT. THE SAMPLES RECEIVED FOR INVESTIGATION HAVE CONFIRMED THE DEFECTS REPORTED BY THE CUSTOMER. THERE ARE MULTIPLE DEFECTS REPORTED IN THIS COMPLAINT. THE PROBABLE ROOT CAUSE AND THE ACTION PLAN FOR EACH IS AS FOLLOWS. THE PROBABLE ROOT CAUSE: BARREL FLANGE DAMAGE- SERVO NOT COVERING DESIRED DISTANCE WHILE TRANSFERRING BARREL FROM MARKING STATION TO ASSEMBLY. ACTIONS FOR BARREL FLANGE DAMAGE: SERVO MOTOR INSTALLED TO TRANSFER BARREL FROM MARKING INDEX TO ASSEMBLY INDEX SHOULD RAISE ALARM IF SERVO HAS NOT COVERED THE DESIRED DISTANCE. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 19,390 DISCARDIT II 2 ML WITH 25G X 1 EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO NEEDLE, DOUBLE NEEDLE, DAMAGED SYRINGE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 · 1

    IT WAS REPORTED THAT 19,390 DISCARDIT II 2 ML WITH 25G X 1 EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO NEEDLE, DOUBLE NEEDLE, DAMAGED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108561 DISCARDIT II 2 ML WITH 25G X 1 SYRINGE FMF BECTON DICKINSON 0214097

    Patients

    Seq Age Sex Outcome Treatment
    1