BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE XS

    MDR report key: 10544470 · Received September 16, 2020

    Report

    Report Number
    9616657-2020-00151
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 25, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9213635 AND 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, THREE PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE PRODUCT PACKAGING WAS OBSERVED TORN. IT HAS BEEN DETERMINED THAT THIS DAMAGE RESULTED FROM AN ERROR ASSOCIATED WITH THE MANUFACTURING FACILITY'S PERFORATION STATION. THE BLADE MAINTENANCE PROGRAM FOR THIS MACHINERY HAS BEEN UNDER REVIEW. THE TIME FRAME BETWEEN BLADE REPLACEMENTS HAS SINCE BEEN DECREASED TO PREVENT POOR PERFORATION IN THE BLISTER PRODUCT PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML SALINE XS HAD A DAMAGED PACKAGE WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""DEAR SUPPLIER, WE HAVE RECEIVED A COMPLAINT IN RELATION TO PRODUCT BD306572 LOT/BATCH 9213635 REF. (B)(4), PLEASE SEE ATTACHED PICTURES. THE CUSTOMER STATES THAT: ¿DAMAGED WRAPPING FOR NACL FLUSH TAKEN OUT OF AN ANCIL PACK. THE PATIENT CURRENTLY HAS THE FLUSH STILL PLEASE LET US KNOW IF THIS NEEDS RETURNING.¿ PLEASE CAN YOU LAUNCH AN INVESTIGATION TO DETERMINE WHY THIS OCCURRED AND SUPPLY AN INVESTIGATION REPORT DETAILING YOUR FINDINGS. IF YOU REQUIRE ANY FURTHER INFORMATION PLEASE DO NOT HESITATE TO CONTACT ME AT THE DETAILS BELOW. PLEASE ACKNOWLEDGE THIS COMPLAINT WITHIN 24 HOURS AND PROVIDE AN ESTIMATED COMPLETION DATE FOR YOUR INVESTIGATION. THANK YOU. ""

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6); INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10 ML SALINE XS HAD A DAMAGED PACKAGE WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEAR SUPPLIER, WE HAVE RECEIVED A COMPLAINT IN RELATION TO PRODUCT BD306572 LOT/BATCH 9213635 REF. (B)(4), PLEASE SEE ATTACHED PICTURES. THE CUSTOMER STATES THAT: ¿DAMAGED WRAPPING FOR NACL FLUSH TAKEN OUT OF AN ANCIL PACK. THE PATIENT CURRENTLY HAS THE FLUSH STILL PLEASE LET US KNOW IF THIS NEEDS RETURNING.¿ PLEASE CAN YOU LAUNCH AN INVESTIGATION TO DETERMINE WHY THIS OCCURRED AND SUPPLY AN INVESTIGATION REPORT DETAILING YOUR FINDINGS. IF YOU REQUIRE ANY FURTHER INFORMATION PLEASE DO NOT HESITATE TO CONTACT ME AT THE DETAILS BELOW. PLEASE ACKNOWLEDGE THIS COMPLAINT WITHIN 24 HOURS AND PROVIDE AN ESTIMATED COMPLETION DATE FOR YOUR INVESTIGATION. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009075 SYRINGE 10ML SALINE XS SYRINGE FMF BECTON, DICKINSON AND CO. 9213635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other