BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUMCISION CLAMP, SIZE: 1.3 CM

    MDR report key: 4717930 · Received April 21, 2015

    Report

    Report Number
    2320762-2015-00006
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    October 21, 2013
    Report Date
    April 17, 2015
    Manufacturer
    G.A. SURGICAL (PVT) LTD
    Product Code
    HFX
    PMA / PMN Number
    K043533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE REPORT WAS RECEIVED, THE QC COMPLAINT SPECIALIST REVIEWED THE WORK ORDER TO OBTAIN THE RAW MATERIAL LOT NUMBER IN REFERENCE TO THE REPORT. RAW MATERIAL (B)(4), LOT NUMBER PO 1160146. THE QC COMPLAINT SPECIALIST REVIEWED THE LOT ORDER INQUIRY TO IDENTIFY THE FINISHED GOOD LOT NUMBERS THT INCLUDED THE RAW MATERIAL AND RAW MATERIAL LOT NUMBER. SEE FINISHED GOOD LOT NUMBER QUANTITY PRODUCED : 32-1622; 33423747; (B)(4), 32-1622; 33444071; (B)(4), 32-1622; 33347799; (B)(4). A REQUEST HAS BEEN SENT TO EACH OF THE FACILITIES THAT UTILIZE THE RAW MATERIAL TO PLACE THE IDENTIFIED LOT NUMBER UNDER QUARANTINE. IN ADDITION, A REQUEST WAS SUBMITTED TO DDC TO REQUEST EACH OF THE FINISHED GOODS IDENTIFIED BE PLACED UNDER QUARANTINE DUE TO CUSTOMER COMPLAINTS RECEIVED IN REFERENCE TO THE ISSUES WITH THE PRODUCT. (B)(4) HAS BEEN ISSUED TPO THE VENDOR. THE VENDOR RESPONDED WITHIN A LETTER ON THEIR COMPANY LETTERHEAD. WITHIN THE RESPONSES IT WAS INDICATED THE QUALITY ISSUES ARE DUE TO THE ISSUES THAT OCCURED WAS DUE TO THE PRODUCT NOT BEING PROPERLY INSPECTED. IN ADDITION, THE VENDOR HAS RESPONDED STATING THT A PLASTIC WASHER IS NOT PARTY ODF THEIR PRODUCTS DESIGN. UPDATED: A FURTHER REVIEW OF THE COMPLAINT HAS IDENTIFIED THAT THE COMPLAINT WILL BE REQUIRED FOR UPDATES. DEROYAL REGULATORY DÉPARTEMENT HAS BEEN NOTIFIED OF THE RE-OPENING OF THE REPORT. AFTER THE COMPLETION OF THE INITIAL INVESTIGATION, THE FINISHED GOOD AND LOT NUMBER IDENTIFIED WAS INCLUDED WITHIN A DEROYAL RECALL THAT WAS LIMITED TO THE FINISHED GOODS THAT CONTAINED THE (B)(4) INSTRUMENT SUPPLIED CIRCUMCISION CLAMPS. THE (B)(4) CIRCUMCISION CLAMPS WERE IDENTIFIED AS BEING A ONE-TIME PURCHASE BY DEROYAL SUPPLY CHAIN DUE TO A BACKORDER SITUATION WITH OUR PRIMARY VENDOR. IT WENT UNNOTICED THAT THE WASHER WAS NOT PART OF THE DESIGN. TO ADDRESS THE ISSUE INTERNALLY DEROYAL INITIATED CAPA ACTION POINT (B)(4). THIS ACTION POINT HAS BEEN COMPLETED AND VERIFIED EFFECTIVE. REFER TO THE (B)(4) ATTACHMENT AS EVIDENCE. AS PER THE CUSTOMER'S REQUEST, A REPLACEMENT HAS BEEN SHIPPED ON ORDER #(B)(4). THE FINISHED GOOD AND RAW MATERIAL INVENTORY HAS BEEN REMOVED FROM AVAILABILITY AND SUBJECTED TO THE RECALL PROCESS. SCAR: (B)(4) IDENTIFIED THE ISSUE REPORTED WAS DUE TO THE NEGLIGENCE OF Q.C. AND FINAL INSPECTION AND PACKAGING. THE REPORTED ISSUE OF MISSING THE WASHER HAS BEEN IDENTIFIED THAT DEROYAL SUPPLY CHAIN APPROVING THE RECEIPT OF THE PRODUCT FROM THE VENDOR IN WHICH THEIR DESIGN DOES NOT CONTAIN A WASHER. A POTENTIAL ROOT CAUSE OF THE PRODUCT FAILING TO PROVIDE THE ADEQUATE FORCE CAN BE CONTRIBUTED TO THE PRODUCT BEING OUT OF SPECIFICATION. THE PRODUCT BEING MANUFACTURED AND SUPPLIED TO DEROYAL OUT OF SPECIFICATION WAS DUE TO A VENDOR RELATED ISSUE AS PART OF THEIR MANUFACTURING PROCESS AND FAILURE TO IDENTIFY THE ISSUE DURING THE (B)(4) QC AND FINAL INSPECTION PROCESS. SCAR: REPLACING OF QC PERSON WITH WELL TRAINED PERSONNEL AND STRICT INSTRUCTION ISSUED TO FOLLOW ALL GUIDELINES. THIS ACTION IS BASED ON THE POTENTIAL ROOT CAUSE THOUGHT TO BE NEGLIGENCE AND HUMAN ERROR. DEROYAL PURCHASED THE PRODUCT FROM THE IDENTIFIED VENDOR THROUGH A ONE-TIME PURCHASE AND DEROYAL SUPPLY CHAIN MANAGEMENT HAS BEEN MADE AWARE OF THE QUALITY ISSUES WITH THE (B)(4) SUPPLIED PRODUCT. DEROYAL ISSUED A RECALL THAT INCLUDED THE FINISHED GOOD AND LOT NUMBER REPORTED AND PRODUCT THAT CONTAINED ONLY THE (B)(4) SUPPLIED RAW MATERIALS. RECALL #300040625-01/27/2014-001-R. SCAR: IN FUTURE, QC DEPARTMENT WILL STRICTLY FOLLOW THE GUIDELINES AND MONITOR ALL QUALITY ISSUES TO AVOID SUCH COMPLAINTS. DEROYAL DECIDED TO OBSOLETE THE PRODUCT LINE AND NO LONGER RELEASE THE PRODUCT FOR COMMERCIAL DISTRIBUTION. THIS DECISION WAS ANNOUNCED BY THE PATIENT PROTECTION/FOAM/NEONATAL/ANGIO MARKETING MANAGER ON 10/23/2014. THERE WERE NO RECALLS ASSOCIATED WITH THE DETERMINATION OF DISCONTINUING THE PRODUCT LINE DUE TO THE ENCOMPASSING OF THE FULL PRODUCT LINE THAT CONTAINS CIRCUMCISION CLAMPS.

    Description of Event or Problem · 1

    CLAMP SEEMS TO HAVE CHANGED, NO WASHER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262004 CIRCUMCISION CLAMP, SIZE: 1.3 CM HFX G.A. SURGICAL (PVT) LTD 33347799

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention