BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 9587480 · Received January 14, 2020

    Report

    Report Number
    1911916-2020-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 23, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN CORRECTED: H.3. REASON CODE FOR NO EVALUATION: OTHER, H.3. IF OTHER SPECIFY: SEE H.10 H3 OTHER TEXT : SEE H.10,

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653, BATCH NO: 9240206, CUSTOMER CALLED 12/27 STATING THAT TWO BOXES OF PRODUCT HAD SYRINGES IN PACKAGES THAT WERE NOT SEALED. UNSURE IF THEIR THIRD BOX HAS THE SAME ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE (3) PHOTOS WERE PROVIDED FOR INVESTIGATION. ALL THREE (3) PHOTOS SHOW SYRINGE BLISTER PACKS WHICH APPEAR TO NOT HAVE BEEN COMPLETELY SEALED. OPEN SEALS ARE LIKELY CAUSED BY A LOAD CELL FAULT ON THE PACKAGER WHERE THE OPERATOR OR SETUP DIDN'T CLEAR THE ROW OF UNSEALED PACKAGES FROM THE FAULT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE FOR LOT #9240206 ITEM #309653. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: OPEN SEALS ARE LIKELY CAUSED BY A LOAD CELL FAULT ON THE PACKAGER WHERE THE OPERATOR OR SETUP DIDN'T CLEAR THE ROW OF UNSEALED PACKAGES FROM THE FAULT. RATIONALE: BD ACKNOWLEDGES THAT THE PHOTOS PROVIDED APPEAR TO SHOW BLISTER PACKS WHICH WERE NOT SEALED PROPERLY. THIS IS THE FIRST (1ST) COMPLAINT OF OPEN SEALS FOR THIS BATCH WITH AN UNKNOWN NUMBER OF OCCURRENCES. AS THE NUMBER OF OCCURRENCES IS NOT KNOWN AN OCCURRENCE RATE CANNOT BE DETERMINED FOR THE BATCH; THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653 BATCH NO: 9240206. CUSTOMER CALLED 12/27 STATING THAT TWO BOXES OF PRODUCT HAD SYRINGES IN PACKAGES THAT WERE NOT SEALED. UNSURE IF THEIR THIRD BOX HAS THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52148 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9240206 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other