BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN BLS 100BX AU

    MDR report key: 9826690 · Received March 12, 2020

    Report

    Report Number
    1920898-2020-00243
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 27, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL CONTENT (NO LOT), SHELF CARTON DAMAGED (STAIN) ON LOT # 9140735. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1/2CC, 12.7MM, 29G SYRINGES FROM LOT # 9140735. CUSTOMER STATES THAT THERE IS NO LOT AND THERE IS A STAIN. THE PHOTOS WERE EXAMINED AND EXHIBITED TORN SHELF CARTONS AS WELL AS SHELF CARTONS WITH NO LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE INFORMATION PRINTED ON THE SHELF CARTONS. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140735 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200838973] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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. 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. ROOT CAUSE DESCRIPTION: ON 03MAR2020, (B)(4) RECEIVED A COMPLAINT, FROM MATERIAL 326769, BATCH 9140735. VISUAL INSPECTION OF THE PICTURES FOUND SEVERAL CARTONS WITH MISSING LOT CODING AND OTHERS WITH A NARROW VERTICAL DELAMINATION DOWN THE BACK OF THE CARTON. PROCESS SUMMARY: THE BLISTERPACK MACHINE PACKAGES THE SYRINGES INTO A SEQUENCE OF INDIVIDUALLY FORMED POCKETS IN THE BOTTOM WEB THAT IS HEAT-SEALED WITH THE TOP WEB AND THEN CUT INTO INDIVIDUAL BLISTERS. SEALED BLISTERS ARE THEN CONVEYED AND PICKED AND PLACED INTO A SHELF CARTON. THE FULL CARTONS ARE CONVEYED ACROSS A SCALE TO ENSURE THAT THE CORRECT NUMBER OF SYRINGES HAVE BEEN PLACED IN THE CARTON. THE CARTONS ARE THEN CONVEYED TO THE CASE PACK. ONCE FIVE CARTONS ARE IN POSITION, A SHIPPER CASE IS ERECTED AND THE FIVE CARTONS ARE SHUTTLED INTO THE ERECTED CASE, WHICH IS THEN CONVEYED TO BE TAPED SHUT, LABELED AND PALLETIZED. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES THAT PERTAINED TO THIS DEFECT DURING THE PRODUCTION OF THIS BATCH. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 29GA 1/2IN BLS 100BX AU WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT = 2 SP, STAIN = 3 SP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291132 SYRINGE 0.5ML 29GA 1/2IN BLS 100BX AU SYRINGE FMF BD MEDICAL - DIABETES CARE 9140735

    Patients

    Seq Age Sex Outcome Treatment
    1 Other