BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER BATH STERILITY COVER

    MDR report key: 5707162 · Received June 8, 2016

    Report

    Report Number
    2520274-2016-13071
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Report Date
    May 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JTQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE EVALUATION HAS SHOWN THAT THE ACRYLIC GLASS STERILITY COVER FOR THE WATER BATH IS CRACKED, WITHOUT FRAGMENTATION, AT ITS WEAKEST POINT. THE OVERALL CONDITION OF THE COVER IS VERY USED WITH SCRATCHES ALL OVER AND A DULL SURFACE. BASED ON THIS INFORMATION, IT CAN BE CONCLUDED THAT THIS WAS AN OFTEN AND INTENSELY USED LOAN SET DEVICE. ALSO, THIS COVER WAS PHASED OUT IN MARCH, 2011. A REVIEW OF SHIPMENT TRANSACTIONS HAS SHOWN THAT THIS PART WAS LAST SHIPPED TO (B)(4) IN MAY, 2008. BASED ON THIS INFORMATION, IT CAN BE ASSUMED THAT THIS DEVICE IS AT LEAST EIGHT (8) YEARS OLD. BASED ON THESE FINDINGS, A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. BASED ON THE COMPLAINT DESCRIPTION, IT CAN BE ASSUMED THAT INAPPROPRIATE HANDLING DURING TRANSPORTATION LED TO THE DAMAGE ON THE COVER. NO PRODUCT RELATED ISSUES WERE DETECTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO REPORTED PATIENT OR SURGICAL INVOLVEMENT. EVENT DATE: THE EXACT DATE OF BREAKAGE IS UNKNOWN; HOWEVER, THE ISSUE WAS DISCOVERED UPON DELIVERY ON (B)(6) 2016. DEVICE PRODUCT CODE ¿XXX¿ IS BEING USED TO REPORT UNAVAILABLE CODE JTQ, WHICH CORRESPONDS WITH THE REPORTED COMMON NAME. PARTIAL UDI NUMBER: (B)(4) LOT UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER HOSPITAL CONTACT NUMBER: (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE STERILE TIP OF THE DEVICE WAS BROKEN DURING TRANSPORT FROM THE WAREHOUSE TO THE HOSPITAL. NO PATIENT OR PROCEDURAL INVOLVEMENT NOTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362451 WATER BATH STERILITY COVER BATH, INCUBATORS, WATER/ALL JTQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1