BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGES

    MDR report key: 16963111 · Received May 19, 2023

    Report

    Report Number
    3002682307-2023-00127
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 25, 2023
    Report Date
    June 26, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 19-MAY-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309050 AND LOT NUMBER 2212151. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) VIDEO SAMPLE AND ONE (1) PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE REPORTED DEFECT OF AIR ENTRY WAS IDENTIFIED. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2212151 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027 H.4. DEVICE MANUFACTURE DATE: 05-DEC-2022 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGES AIR ENTERED THE LINE. THIS OCCURRED ONCE IN LOT 2212151 AND TWICE IN AN UNSPECIFIED LOT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ONE OF OUR IDES HAS ENCOUNTERED A PROBLEM WITH A 5 ML SYRINGE (REF 309050, BATCH NUMBER 2212151 EXP 11/2027) WHEN PREPARING A SYRINGE FOR BOTOX INJECTION. SHE HAS SENT US THE ATTACHED VIDEO, AND BELIEVES THAT AIR IS COMING UP FROM THE PLUNGER OF THE SYRINGE. THIS HAS HAPPENED TO HER WITH SEVERAL OTHER SYRINGES (LOT NUMBER UNKNOWN). THE SYRINGE IS AVAILABLE FOR ANALYSIS AT THE PHARMACY IF NEEDED, IT IS NOT CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGES AIR ENTERED THE LINE. THIS OCCURRED ONCE IN LOT 2212151 AND TWICE IN AN UNSPECIFIED LOT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ONE OF OUR IDES HAS ENCOUNTERED A PROBLEM WITH A 5 ML SYRINGE (REF (B)(4), BATCH NUMBER 2212151 EXP 11/2027) WHEN PREPARING A SYRINGE FOR BOTOX INJECTION. SHE HAS SENT US THE ATTACHED VIDEO, AND BELIEVES THAT AIR IS COMING UP FROM THE PLUNGER OF THE SYRINGE. THIS HAS HAPPENED TO HER WITH SEVERAL OTHER SYRINGES (LOT NUMBER UNKNOWN). THE SYRINGE IS AVAILABLE FOR ANALYSIS AT THE PHARMACY IF NEEDED, IT IS NOT CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479003 BD DISCARDIT¿ II SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown