BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML SYRINGE LUER-LOK TIP

    MDR report key: 10348436 · Received July 30, 2020

    Report

    Report Number
    1911916-2020-00705
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. IT SHOWS A CASE LABEL. THE LABEL HAS TWO LOCATIONS WITH THE CATALOG NUMBER. IN ONE OF THEM, THE LAST DIGIT IS MISSING A ZERO DIGIT. THE OTHER LOCATION IS GOOD. THE LOT# HAS THE LAST DIGIT PARTIALLY PRINTED IN ONE LOCATION. A POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE SYRINGE PACKAGING PROCESS. AFTER THE SYRINGE ASSEMBLY PROCESS, THE SYRINGE GOES TO THE PACKAGING PROCESS. IT MAY HAVE HAPPENED THAT THE LABELS PRINTER HAD A MISADJUSTMENT AND NOT DETECTED IN THE NEXT PROCESS. BASED ON THE PHOTO ANALYSIS AND INVESTIGATION CARRIED OUT, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING AND TRENDING THIS PRODUCT AND THIS SYMPTOM. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WOULD CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 384 BD 20ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302830, BATCH NO: 9120782. ISSUES: WOULD LIKE TO REPORT A LABELING ISSUE FOR THE SECONDARY PACKAGING OF TWO CASES OF 20ML SYRINGES, THE LOT/CATALOG NUMBER WERE CUT OFF. CUSTOMER IS STILL ABLE TO USE THE SYRINGES IN THE CASES HOWEVER THERE WAS A SECONDARY LABELING DISCREPANCY HENCE RAISED THE QUALITY COMPLAINT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) USA HAS BEEN USED AS A DEFAULT.  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 384 BD 20ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302830 BATCH NO: 9120782. ISSUES: WOULD LIKE TO REPORT A LABELING ISSUE FOR THE SECONDARY PACKAGING OF TWO CASES OF 20ML SYRINGES, THE LOT/CATALOG NUMBER WERE CUT OFF. CUSTOMER IS STILL ABLE TO USE THE SYRINGES IN THE CASES HOWEVER THERE WAS A SECONDARY LABELING DISCREPANCY HENCE RAISED THE QUALITY COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812664 BD 20ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 9149674 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other