BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN AND SCALP CLIPS AND RETRACTORS

    MDR report key: 7500325 · Received May 9, 2018

    Report

    Report Number
    3003898360-2018-00327
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE REPRESENTATIVE SAMPLE OF 382800 DURAHOOK 1/4 HOOK 10 PKG/BOX 6 HKS/PKG FOR INVESTIGATION. THE ACTUAL SAMPLE WAS NOT RETURNED. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THERE ARE MULTIPLE BANDS THAT SHOWED SIGNS OF DISCOLORATION. THE DISCOLORATION OF THE BANDS IS A SIGN THAT THE BANDS HAD OVER-EXPOSURE TO HEAT AND/OR UV LIGHTING. REFERENCE FILE (B)(4) FOR INVESTIGATION PHOTOS. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE DURABILITY OF THE RETURNED SAMPLE. ALL SIX DURAHOOKS WERE TESTED. THE DURAHOOK WAS ATTACHED TO A FORCE GAUGE VIA THE THERMOPLASTIC ELASTOMETRIC (TPE) BAND AND STRETCHED TO MEASURE THE AMOUNT OF FORCE ON THE BAND. THE TESTED DURAHOOKS YIELDED THE FOLLOWING RESULTS: 1ST TPE BAND: 3.35 LB-FORCE WITHOUT SNAPPING 2ND TPE BAND: 3.78 LB-FORCE WITHOUT SNAPPING 3RD TPE BAND: 3.62 LB-FORCE WITHOUT SNAPPING 4TH TPE BAND: 3.13 LB-FORCE WITHOUT SNAPPING 5TH TPE BAND: 3.33 LB-FORCE WITHOUT SNAPPING 6TH TPE BAND: 3.33 LB-FORCE WITHOUT SNAPPING OTHER REMARKS: NONE OF THE TESTED SAMPLES BROKE. ACCORDING TO DHF D001915, "THE BAND SHALL BE ABLE TO STRETCH TO AT LEAST DOUBLE OR 200% ITS ORIGINAL LENGTH WITH A FORCE OF 0.79 0.15 LB-FORCE" AND "AT LEAST TRIPLE OR 300% ITS ORIGINAL LENGTH WITH A FORCE OF 0.90 0.17 WITHOUT BREAKING." ALL SAMPLES WERE ABLE TO WITHSTAND AT LEAST 3.13 LB-FORCE WITHOUT BREAKING WHICH FAR EXCEEDS THE REQUIREMENT. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLES. SPECIFICATIONS PER GRAPHIC 14-2-001470 REV. 01 AND THE DHF FOR THIS PRODUCT, D001915 REV. 03, WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME SINCE NO FUNCTIONAL DEFECTS WERE FOUND WITH THE RETURNED SAMPLE. ONE REPRESENTATIVE SAMPLE WAS RETURNED. THE ACTUAL SAMPLE WAS NOT RETURNED. THE REPORTED COMPLAINT OF "BRITTLE/BREAKING" WAS NOT CONFIRMED BASED UPON THE SAMPLES RECEIVED. ONE REPRESENTATIVE SAMPLE WAS RETURNED, BUT THE ACTUAL SAMPLE WAS NOT. MULTIPLE BANDS SHOWED SIGNS OF DISCOLORATION WHICH INDICATES THAT THE SAMPLE WAS OVER-EXPOSED TO HEAT AND/OR UV LIGHTING. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE DURABILITY OF THE RETURNED SAMPLE. THE STRENGTH OF THE TPE BAND WAS TESTED VERSUS THE DESIGN SPEC AND ALL TESTED SAMPLES FAR EXCEEDED THE REQUIREMENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED DURAHOOKS. SINCE ONLY A REPRESENTATIVE SAMPLE WAS RETURNED, THE ROOT CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ELASTIC SEEMS TO BE BRITTLE AND/OR BREAKING. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG (B)(4) INVESTIGATIONS DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELASTIC SEEMS TO BE BRITTLE AND/OR BREAKING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343185 SKIN AND SCALP CLIPS AND RETRACTORS GAG TELEFLEX MEDICAL 73H1700648

    Patients

    Seq Age Sex Outcome Treatment
    1