BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE TW BLS 400 SG

    MDR report key: 8474374 · Received April 2, 2019

    Report

    Report Number
    1920898-2019-00305
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (222) 1/2ML, 8MM, 30G BD SAFETYGLIDE INSULIN SYRINGES IN SEALED BLISTER PACKS FROM LOT # 8211637. CUSTOMER STATES THAT THERE IS NO EXPIRATION DATE ON CERTAIN PACKAGES. THE CUSTOMER RECALLS PRODUCTS WITH THIS LOT NUMBER. THEREFORE, THE ACTUAL QUANTITY IS STILL UNDER CALCULATION. ALSO, THE CUSTOMER THINKS THAT THE LOT NUMBER WITH DIFFERENT SUFFIX A OR B OR C OR D¿¿SHOULD BE CONSIDERED AS DIFFERENT LOT NUMBERS WHILE RECEIVING UNIT PACKAGE. ALL RETURNED SYRINGES WERE EXAMINED AND 19 OUT OF 222 SAMPLES EXHIBITED NO LOT NUMBER OR EXPIRATION DATE INFORMATION PRINTED ON THE BLISTER PACK. ALSO, ON THE SAMPLES WHERE THE LOT NUMBER WAS PRINTED, THERE WAS A DIFFERENT LETTER AFTER LOT NUMBER PRINTED ACROSS THE SAMPLES. THE LETTER AT THE END OF THE PRINTED LOT# IS NOT A PART OF THE UNIQUE 7-DIGIT BATCH ID. THE LETTER IS FOR IDENTIFICATION OF WHICH LANE ON THE PRODUCTION EQUIPMENT THAT THIS PARTICULAR SWAB WAS PACKAGED ON. THIS IS A METHOD OF MAINTAINING TRACKING AND TRACEABILITY, IN THE EVENT WE HAVE AN ISSUE IN PRODUCTION OR FROM THE CONSUMER, SO WE CAN INVESTIGATE ROOT CAUSES EFFECTIVELY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8211637. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NO LOT PRINTED ON THE BLISTER PACK). 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. AS PER MANUFACTURING, "PROBABLE ROOT CAUSE OF MISSING LOT CODE PRINT IS FROM AN IMPROPER WEB CHANGE THAT DID NOT VERIFY PRINT AFTER THE CHANGEOVER. THE PRINT MUST BE VERIFIED AFTER PRINTING ON THE TOP WEB BEFORE PACKAGED PRODUCT IS RUN ON THE MACHINE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL OF BD¿ SYRINGE TW BLS 400 SG DID NOT HAVE THE EXPIRATION DATE ON CERTAIN PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ NO EXPIRATION DATE ON CERTAIN PACKAGES. THE CUSTOMER RECALLS PRODUCTS WITH THIS LOT NUMBER. THEREFORE, THE ACTUAL QUANTITY IS STILL UNDER CALCULATION. ALSO, THE CUSTOMER THINKS THAT THE LOT NUMBER WITH DIFFERENT SUFFIX A OR B OR C OR D¿¿SHOULD BE CONSIDERED AS DIFFERENT LOT NUMBERS WHILE RECEIVING UNIT PACKAGE. ¿

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE LABEL OF BD¿ SYRINGE TW BLS 400 SG DID NOT HAVE THE EXPIRATION DATE ON CERTAIN PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ NO EXPIRATION DATE ON CERTAIN PACKAGES. THE CUSTOMER RECALLS PRODUCTS WITH THIS LOT NUMBER. THEREFORE, THE ACTUAL QUANTITY IS STILL UNDER CALCULATION. ALSO, THE CUSTOMER THINKS THAT THE LOT NUMBER WITH DIFFERENT SUFFIX A OR B OR C OR D¿¿SHOULD BE CONSIDERED AS DIFFERENT LOT NUMBERS WHILE RECEIVING UNIT PACKAGE. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265302 BD SYRINGE TW BLS 400 SG SAFETY SYRINGE MEG BD MEDICAL - DIABETES CARE 8211637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other