BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12061200 · Received June 24, 2021

    Report

    Report Number
    1213809-2021-00451
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS SHOWED THE EXTERIOR OF A 10ML BULK NON-STERILE (MATERIAL 301029) BOX FROM MULTIPLE ANGLES. THE BOX WAS NUMBERED "400" WITH BLACK MARKER AND WAS MISSING AN IDENTIFYING LABEL. DEVICE HISTORY RECORD REVIEW: ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH NUMBER 1082724 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A COMPLAINT HISTORY CHECK WAS PERFORMED NO ADDITIONAL COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LABEL / PRODUCT INSERT MISSING WITH BATCH NUMBER 1082724 REGARDING MATERIAL 301029. TREND ANALYSIS PERFORMED FOR DEFECT/CONDITION OF LABEL / PRODUCT INSERT MISSING REPORTED IN BATCH NUMBER 9273353 AND 8088518 REGARDING MATERIAL 301029. POTENTIAL ROOT CAUSE FOR THE MISSING LABEL DEFECT IS ASSOCIATED WITH FAILURE TO FOLLOW PROCEDURE DURING THE BULK PACKAGING PROCESS. THE PROCESS FOR VERIFYING PROPER LABEL PLACEMENT ON ALL BULK NON-STERILE SHIPMENTS WAS UPDATED AND RELEASED APRIL 5TH 2021. INTERNAL PROCEDURE ALLOWS A GRACE PERIOD OF 28 DAYS FOR ASSOCIATES TO EDUCATE TO ANY UPDATES TO DOCUMENTATION. SINCE THIS BATCH WAS MANUFACTURED BETWEEN APRIL 14TH 2021 TO APRIL 16TH 2021, NO CORRECTIVE ACTIONS ARE NECESSARY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASE OF BD LUER-LOK¿ TIP SYRINGES HAD NO EXPIRATION DATE OR LOT# LISTED ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 CASE OUT OF THE 15 CASES UNDER PO 85992 WAS RECEIVED WITH MISSING LABELING (LOT# & EXPIRATION DATE IS REQUIRED FOR THIS COMPONENT)."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CASE OF BD LUER-LOK" TIP SYRINGES HAD NO EXPIRATION DATE OR LOT# LISTED ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 CASE OUT OF THE 15 CASES UNDER (B)(4) WAS RECEIVED WITH MISSING LABELING (LOT# & EXPIRATION DATE IS REQUIRED FOR THIS COMPONENT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959141 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1082724

    Patients

    Seq Age Sex Outcome Treatment
    1