BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP

    MDR report key: 7484356 · Received May 3, 2018

    Report

    Report Number
    2243072-2018-00223
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 13, 2018
    Report Date
    June 18, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7261929. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7225923. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7272938. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7230933. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BDJ RECEIVED 6 BOXES. (2 BOXES OF LOT 7261929, 2 BOXES OF LOT 7225923, 1 BOX OF LOT 7272938 AND 1 BOX OF LOT 7230933.) BDJ CHECKED HALF LIDS FROM EACH BOX AND FOUND 1 LID OF LOT7261929(CAVITY#1510-3/2011-1)OPENED IMMEDIATELY AFTER IT WAS SHUT. THE REST COULD KEEP CLOSED OVER 10MIN. ACCORDING TO THIS INVESTIGATION THIS FAILURE MODE IS ALREADY KNOWN SINCE PREVIOUS COMPLAINTS WERE RECEIVED FOR THE SAME CONDITION THROUGHOUT 2017 REASON WHY A CAPA RECORD # (B)(4) WAS OPENED TO PERFORM THE INVESTIGATION AND TO IMPLEMENT CORRECTIVE ACTIONS. IT WAS NOT CONFIRMED IF THE DEFECTIVE PRODUCT REPORTED IN THIS COMPLAINT AROSE FROM A LOT MANUFACTURED AFTER OF THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS DUE TO THE LOT NUMBER WAS UNKNOWN. CORRECTIVE ACTIONS WERE FULL IMPLEMENTED FOR BATCHES MANUFACTURED FROM 2018 ONWARDS. INVESTIGATION CONCLUSION: BASED ON THIS INVESTIGATION THIS FAILURE MODE WAS CAUSED DUE WORN OUT ON THE MOLD, THE CORRECTIVE ACTIONS WERE IMPLEMENTED AND EVALUATED AS EFFECTIVE. ROOT CAUSE SLOT REFERENCE DIME:NSION WAS FOUND GREATER (LOOSE) THAN DRAWING SPECIFICATION. SUPPLIER CORRECTIVE ACTIONS ALIGN STEEL AS PER DRAWING REQUIREMENT. CREATE MOLD INSERTS TO BE REPLACED IF NEEDED, DURING PREVENTIVE MAINTENANCE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPORARY LIDS OF A BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP DIDN¿T SHUT. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324997 BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other