BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8402, M ALEXIS O WND PROT/RET 5/BX

    MDR report key: 9453822 · Received December 11, 2019

    Report

    Report Number
    2027111-2019-00659
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    August 22, 2019
    Report Date
    January 7, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117269
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE HEAT SEAL ON THE POUCH HAD DELAMINATED. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THAT THE STERILE BARRIER HAD BEEN COMPROMISED. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY ROUGH HANDLING DURING THE BOXING, SHIPPING, AND/OR HANDLING PROCESSES. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: CER 1 OF 3: 2019-002370 - C8304 LOT# 1358751 - BUG IN POUCH - 1 POUCH CER 2 OF 3: 2019-002386 - C8402 LOT# 1358548 - IMPERFECT HEAT SEAL - 1 POUCH CER 3 OF 3: 2019-002463 - G6313 LOT# 1358693 - TORN SHEATH - 1 POUCH THE PRODUCT DID NOT PASS THE INCOMING INSPECTION OF PO#19-10APP BECAUSE OF BUG. DETAILS ARE SHOWN ON THE ATTACHED FILE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30SEP2019 FROM APPLIED MEDICAL DIRECTOR PACKAGING: "PACKAGING WILL NEED A CER FOR ITEM 10 (IMPERFECT HEAT SEAL)." PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA.

    Additional Manufacturer Narrative · 1

    THE EVENT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: CER 1 OF 3: (B)(4) - C8304 LOT# 1358751 - BUG IN POUCH - 1 POUCH. CER 2 OF 3: (B)(4) - C8402 LOT# 1358548 - IMPERFECT HEAT SEAL - 1 POUCH. CER 3 OF 3: (B)(4) - G6313 LOT# 1358693 - TORN SHEATH - 1 POUCH. THE PRODUCT DID NOT PASS THE INCOMING INSPECTION OF PO#19-10APP BECAUSE OF BUG. DETAILS ARE SHOWN ON THE ATTACHED FILE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30SEP2019 FROM APPLIED MEDICAL DIRECTOR PACKAGING: "PACKAGING WILL NEED A CER FOR ITEM 10 (IMPERFECT HEAT SEAL)." PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244592 C8402, M ALEXIS O WND PROT/RET 5/BX PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER KGW APPLIED MEDICAL RESOURCES C8402 1358548 00607915117269

    Patients

    Seq Age Sex Outcome Treatment
    1