BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1024879-2017-00053

    MDR report key: 6507816 · Received April 20, 2017

    Report

    Report Number
    1024879-2017-00053
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 14, 2017
    Report Date
    May 5, 2017
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6172788, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, DEVICE MANUFACTURE DATE: 06/20/2016. MEDICAL DEVICE LOT #: 16G07T1, MEDICAL DEVICE EXPIRATION DATE: 07/31/2018, DEVICE MANUFACTURE DATE: 07/07/2016. (B)(6). RESULTS: A SAMPLE FOR LOT # 6172788 WAS RETURNED TO THE (B)(4) MANUFACTURING SITE FOR EVALUATION. A MANUAL INSPECTION OF THE SAMPLE DID NOT IDENTIFY DIFFICULTY ACTIVATING THE SAFETY SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6172788. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FOR LOT # 6172788. A SAMPLE OF LOT # 16G07T1 HAS BEEN SENT TO THE OEM MANUFACTURING SITE (B)(4) FOR INVESTIGATION. AN EVALUATION OF THAT DEVICE IS ANTICIPATED BUT AS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE UNUSED SAMPLE IN A SEALED PACKAGE WAS RETURNED TO AND EVALUATED BY THE OEM MANUFACTURING SITE (B)(4). A VISUAL INSPECTION OBSERVED NO DEFECTS. A BREAKAWAY FORCE TEST TO MEASURE THE FORCE TO MOVE THE SAFETY SHIELD TO LOCK IN PLACE OVER THE NEEDLE TIP WAS CONDUCTED AND THE RESULT WAS WITHIN SPECIFICATION. A VISUAL INSPECTION OF TEN RETENTION SAMPLES REVEALED NO DEFECTS. A BREAKAWAY FORCE TEST ON THE RETENTION SAMPLES ALSO SHOWED RESULTS WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 16G07T1. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF A 21 G X 0.75 IN. BD VACUTAINE® SAFETY-LOK¿ BLOOD COLLECTION SET WAS SLOW, NOT SMOOTH, CLUNKY, AND DRAGGED WILE ACTIVATING IT AFTER PATIENT USE. THIS DEVICE IS USED APPROXIMATELY TWENTY TIMES PER DAY AND THE SLOW ACTIVATION WAS NOTICED ON A FEW OF THE DEVICES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other