BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 NS 20ML

    MDR report key: 10348364 · Received July 30, 2020

    Report

    Report Number
    3003152976-2020-00331
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 7, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS COMPLETED ON MATERIAL NUMBER 309210 AND LOT NUMBERS 9170677 AND 9238609. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM AND IT WAS OBSERVED THAT THE SYRINGE BARREL TIP WAS BROKEN. DURING THE PRODUCTION PROCESS, THERE IS A DETECTION SYSTEM IN PLACE TO REJECT SYRINGES WITH BROKEN PARTS, LIKE THE TIP OF THE BARREL. IT IS POSSIBLE THAT INCIDENT RESULTED FROM IMPERCEPTIBLE DAMAGE TO THE BARREL THAT COULD HAVE PRODUCED BREAKAGE AT THE TIP DURING USE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES S2 NS 20ML EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INSERTING AN INDWELLING CATHETER FOR AN EMERGENCY CAESAREAN SECTION, THE TIP OF THE 20 ML SYRINGE BROKE OFF IN THE URINARY CATHETER VALVE. THE BALLOON COULD NOT BE INFLATED.

    Additional Manufacturer Narrative · 1

    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: MEDICAL DEVICE LOT #: 9170677, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-06-19, MEDICAL DEVICE LOT #: 9238609, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-26. 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 AN UNSPECIFIED NUMBER OF SYRINGES S2 NS 20 ML EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INSERTING AN INDWELLING CATHETER FOR AN EMERGENCY CAESAREAN SECTION, THE TIP OF THE 20 ML SYRINGE BROKE OFF IN THE URINARY CATHETER VALVE. THE BALLOON COULD NOT BE INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808542 SYRINGE S2 NS 20ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other