BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THIN PREP PAP 500 TSTS/CS

    MDR report key: 5614229 · Received April 28, 2016

    Report

    Report Number
    1216677-2016-00007
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    February 3, 2016
    Report Date
    July 5, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    OHL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT: (B)(4). FOLOW UP INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR INSPECT RETURNED SAMPLES X-INSPECT STOCK PRODUCT ANALYSIS AND FINDINGS AN EVALUATION OF THE COMPLAINANT SAMPLES COULD NOT BE CONDUCTED SINCE THEY WILL NOT BE RETURNED. THE PLASTIC SPATULAS, PART NUMBER 11080B, ARE MOLDED AT COOPERSURGICAL. THE SPATULAS ARE PLACED INTO A BAG WITH BRUSHES AND THE IFU. THE 20 BAGS ARE PLACED INTO A BOX WHICH IS SHIPPED TO THE CUSTOMER. A REVIEW OF THE DHR DID NOT FIND ANY ABNORMALITIES. A SAMPLING OF SPATULAS STOCK INVENTORY WERE TAKEN AND IN SOME CASES, FLASH WAS FOUND AT THE DISTAL END OF THE PART. THIS WAS TRACED BACK TO LOT NUMBERS 171854 AND 171855 ONLY. NON-CONFORMING MATERIAL REPORT (NCMR) 2653 WAS ISSUED TO DOCUMENT THE NON-CONFORMITY. CORRECTION AND/OR CORRECTIVE ACTION ALL STOCK INVENTORY OF LOT NUMBERS 171854 AND 171855 WERE SCRAPPED. CHANGED THE NOZZLE TIPS IN EACH CAVITY TO BETTER CONTROL THE AMOUNT OF MATERIAL IN THE MOLD. QUALITY ALERT QA-00012 WAS ISSUED AND PLACED AT THE MOLDING STATION AND THE PACKING STATION. APPROPRIATE PERSONNEL WERE TRAINED TO THE QUALITY ALERT . CORRECTIVE ACTION LEVEL 2 X-TRAIN PERSONNEL WAS THE COMPLAINT CONFIRMED? YES REVIEW AND CLOSURE X-RECOMMENDED CONTINUOUS IMPROVEMENT PROGRAM (CIP) CAPA REQUIRED? COMPLAINT CLOSURE LETTER REQUIRED? NCMR ISSUED? OTHER REGULATORY ACTION NEEDED: *PREVENTATIVE ACTION ACTIVITY REVIEWED. TREND AND MONITOR TO CIP.

    Description of Event or Problem · 1

    "END USER COMPLAINS THAT BAG OF SPATULAS HAS SOME SHARP PLASTIC AROUND COLLECTION TYPE THAT THE EDGES THAT ARE SHARP AND CUTTING PATIENTS AND CAUSING BLEEDING . THERE ARE A LEAST A FEW SPATULAS IN ALL BAGS ACCORDING TO CUSTOMER. THE END USER WOULD NOT LIKE REPLACEMENTS. THEY JUST WANT THE SPATULAS TO ALL BE THE SAME WITHOUT SHARP EDGES." (B)(4).

    Description of Event or Problem · 1

    "END USER COMPLAINS THAT BAG OF SPATULAS HAS SOME SHARP PLASTIC AROUND COLLECTION TYPE THAT THE EDGES THAT ARE SHARP AND CUTTING PATIENTS AND CAUSING BLEEDING . THERE ARE A LEAST A FEW SPATULAS IN ALL BAGS ACCORDING TO CUSTOMER. THE END USER WOULD NOT LIKE REPLACEMENTS. THEY JUST WANT THE SPATULAS TO ALL BE THE SAME WITHOUT SHARP EDGES." REFERENCE E-COMPLAINT NUMBER : (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272843 THIN PREP PAP 500 TSTS/CS THIN PREP PAP 500 TSTS/CS OHL COOPERSURGICAL, INC. 02500 168875

    Patients

    Seq Age Sex Outcome Treatment
    1