BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 FRENCH DRAIN SYSTEM STERILE

    MDR report key: 7470411 · Received April 27, 2018

    Report

    Report Number
    0008010177-2018-00036
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 17, 2018
    Report Date
    June 12, 2018
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    GCY
    PMA / PMN Number
    K800581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE THE INFORMATION PROVIDED WAS NOT SUFFICIENT AND THE DEVICE WAS NOT RETURNED, AS WAS INITIALLY REPORTED. TO BE ABLE TO FURTHER INVESTIGATE THE EVENT AND DETERMINE A ROOT CAUSE FOR THIS COMPLAINT, THE RESPONSIBLE OR UNIT MANAGER WAS CONTACTED. IT WAS SPECIFIED THAT THE TUBE WAS ALREADY BROKEN INSIDE THE PACKAGING WHEN IT WAS OPENED. THIS WAS NOTICED PRIOR TO CONNECTING IT TO THE HUB. THE CUSTOMER BELIEVES THAT ANOTHER PACKAGE WAS OPENED AS THE STAFF WERE CONCERNED ABOUT THE BROKEN PRODUCT AFFECTING THE INTEGRITY OF THE INITIAL OPENED PACKAGE. IN TERMS OF ¿BROKEN¿ THE TUBE WAS IN SEVERAL DIFFERENT PIECES WITHIN THE PACKAGING AND ¿LOOKED AS THOUGH IT HAD BEEN CRUSHED, DROPPED OR SHATTERED¿. THE OR UNIT MANAGER DISCUSSED ADDITIONALLY WITH ONE OF THE NURSES IF THIS DAMAGE COULD RESULT FROM SOMETHING THAT MAY HAVE HAPPENED IN THE SHIPPING PROCESS HOWEVER THE NURSE COULD NOT COMMENT. THE PROTECTIVE HOUSING WAS USED WHEN THE NEW PACKAGE AND UNDAMAGED TUBES WERE APPLIED. THE PACKAGING WAS DISCARDED, THUS IT IS NOT POSSIBLE TO CONFIRM OR VERIFY THE REPORTED PRODUCT LOT NUMBER. THE DEVICE WAS MANUFACTURED BY STRYKER ORTHOBIOLOGICS IN MALVERN (USA). AFTER A DISCUSSION WITH THE MANUFACTURING SITE IT WAS OBSERVED THAT THE PROVIDED LOT NUMBER M1509019 DOES NOT EXIST. MOST PROBABLY A TYPING ERROR OCCURRED. M1509010 AND M1509009 ARE THE NUMBERS THAT ARE CLOSEST TO THE REPORTED LOT NUMBER. THUS A DHR REVIEW FOR THOSE TWO LOT NUMBERS WAS PERFORMED. ALL RELEVANT DOCUMENTS HAVE BEEN REVIEWED BY THE SUPPLIER. THE DEVICE HISTORY RECORD (DHR) FOR CATALOG # 6640 LOT CODE# M1509009 INDICATES THAT 76 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 2015-OCT-07 WITH NO REPORTED DISCREPANCIES. ADDITIONALLY, THE DEVICE HISTORY RECORD (DHR) FOR CATALOG # 6640 LOT CODE# M1509010 INDICATES THAT (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 2015-OCT-08 WITH NO REPORTED DISCREPANCIES. THE PROVIDED INFORMATION WAS NOT ENOUGH TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT. ACCORDING TO THE CORRESPONDING RISK MANAGEMENT FILE POSSIBLE ROOT CAUSES ARE: A. INSUFFICIENT/ INEFFECTIVE PROTECTIVE PACKAGING . B. DAMAGED PACKAGING DURING SHIPPING OR STORAGE. C. EXCESSIVE FORCES (E.G. VIBRATIONS). BASED ON THE INVESTIGATION AND THE REVIEW OF THE RELEVANT QUALITY AND MANUFACTURING DOCUMENTS THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLASS TUBE WAS BROKEN IN THE PACKAGING BUT WENT UNNOTICED. THE DRAIN WAS PLACED INSIDE THE PATIENT'S SURGICAL WOUND. THERE WAS NO REPORTED SURGICAL DELAY, MEDICAL INTERVENTION, NOR ADVERSE CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLASS TUBE WAS BROKEN IN THE PACKAGING BUT WENT UNNOTICED. THE DRAIN WAS PLACED INSIDE THE PATIENT'S SURGICAL WOUND. THERE WAS NO REPORTED SURGICAL DELAY, MEDICAL INTERVENTION, NOR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313766 7 FRENCH DRAIN SYSTEM STERILE INSTRUMENT GCY STRYKER ORTHOBIOLOGICS-MALVERN EITHER M1509010 OR M1509009

    Patients

    Seq Age Sex Outcome Treatment
    1