BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1.0ML 30GA 8MM 10BAG

    MDR report key: 9491226 · Received December 18, 2019

    Report

    Report Number
    1920898-2019-01440
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 4, 2019
    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 PACKAGE PRINTING DEFECT (DUPLICATE LOT) ON LOT # 9063822. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS FOR 1CC, 8MM, 30G SYRINGES FROM LOT # 9063822. CUSTOMER STATES THAT THERE IS A DUPLICATE LOT. THE PHOTOS WERE EXAMINED AND EXHIBITED A DOUBLE PRINTED LOT ON THE SHELF CARTONS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063822. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD (B)(4), "ON (B)(6) 2019, HOLDREGE RECEIVED PHOTOS OF 1.0ML, 30G, 8MM SHELF CARTONS IN AN OPEN CASE. VISUAL INSPECTION OF THE CARTONS FOUND (2) CARTONS WITH DEFECTS. ONE CARTON HAD LASER PRINT A CROSS THE SIDE OF THE CARTON AND SHADOW PRINT ON THE LOT CODE. ANOTHER CARTON HAD SHADOW PRINT ON THE LOT CODE ONLY. REVIEW OF QUALITY NOTIFICATIONS AND MAINTENANCE DISPATCHES FOUND NO ISSUES RELATED TO THIS COMPLAINT. THE AUTOPACKOUT SYSTEM RECEIVES BAGS OF SYRINGES FROM THE FF&S MACHINE. THE EQUIPMENT ERECTS THE CARTON AND LOADS THE APPROPRIATE AMOUNT OF BAGS OF SYRINGES INTO THE CARTON. THE MACHINE LASER CODES UP TO THREE LINES ON THE CARTON: LOT CODE, DATE OF MANUFACTURE, AND EXPIRATION DATE. THE CARTONS ARE CLOSED BEFORE BEING PLACED ON THE OUTFEED CONVEYOR. IF THE MACHINE IS STOPPED ABRUPTLY DURING THE APPLICATION OF THE LASER CODES; PRINTING DEFECTS CAN BE FOUND. UNABLE TO DETERMINE ROOT CAUSE OF THE DEFECTIVE LASER PRINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORT CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND TREND ON REPORTS MONITORED." RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 1.0ML 30GA 8MM 10BAG HAS BEEN FOUND EXPERIENCING FOUR OCCURRENCES OF LABEL ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DUPLICATE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286574 BD SYRINGE 1.0ML 30GA 8MM 10BAG SYRINGE FMF BD MEDICAL - DIABETES CARE 9063822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other