BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE XS

    MDR report key: 12501926 · Received September 20, 2021

    Report

    Report Number
    9616657-2021-00084
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    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: 2021-10-11. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0223146. 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, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE PRODUCT PACKAGING WAS OBSERVED DAMAGED. HOWEVER, AS THERE WERE NO NON-CONFORMANCES DETECTED WITH THIS PRODUCT, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED. IT IS POSSIBLE THAT AN INCORRECT METHOD OF SEPARATION CAUSED THE PACKAGE DAMAGE OBSERVED AND REPORTED. IT IS RECOMMENDED THAT THE BLISTER PACKAGES ARE SEPARATED ON A HORIZONTAL PLANE. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF DEFECT FOR LOT NUMBER 0223146. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER WAS OBSERVED WITHIN THE PRODUCT PACKAGING. IT HAS BEEN DETERMINED THAT THE FOREIGN MATERIALS WITHIN THE PACKAGES MAY BE RELATED TO TRIM JAMS ON THE MULTIVAC MACHINERY, WHICH COULD HAVE CAUSED CONTAMINATION DUE TO TRIM CATCHING IN THE MACHINE¿S CHAIN. AN ISSUE WAS IDENTIFIED WITH TRIM JAMS WITHIN THE MANUFACTURING FACILITY; HOWEVER, IT WAS RESOLVED AT THE TIME OF OCCURRENCE AND THERE WERE NO NON-CONFORMANCES IDENTIFIED DURING THE PRODUCTION OF LOT NUMBER 0231333. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 10ML SALINE XS HAD POOR PERFORATION AND SUCTION PAPER CAUGHT BETWEEN THE PACKAGING SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DIFFICULTY SEPARATING THE INDIVIDUAL BAGS PRESENCE OF SUCTION PAPER INSIDE AND OUTSIDE (CAUGHT IN THE SEAL) OF THE BAG."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0223146, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 08/10/2020. MEDICAL DEVICE LOT #: 0231333, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 08/18/2020. 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 SYRINGE 10ML SALINE XS HAD POOR PERFORATION AND SUCTION PAPER CAUGHT BETWEEN THE PACKAGING SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DIFFICULTY SEPARATING THE INDIVIDUAL BAGS. PRESENCE OF SUCTION PAPER INSIDE AND OUTSIDE (CAUGHT IN THE SEAL) OF THE BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400511 SYRINGE 10ML SALINE XS NA FMF BECTON, DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown