BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 7331400 · Received March 12, 2018

    Report

    Report Number
    1317056-2018-00026
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    January 4, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS IS ATTEMPTING TO OBTAIN FURTHER DETAIL ON THE EVENT. A SAMPLE WAS STATED TO BE AVAILABLE TO BE RETURNED TO ANGIODYNAMICS, HOWEVER IT HAS NOT YET ARRIVED. UPON RECEIPT OF THE SAMPLE / COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PICC PRODUCT FAMILY FOR THE FAILURE MODE "HUB BROKEN/CRACKED." NO ADVERSE TRENDS WERE INDICATED. THE DEVICE FROM THE REPORTED EVENT WAS RETURNED TO ANGIODYNAMICS, BUT THE SAMPLE WAS UNABLE TO BE LOCATED. THE COMPLAINT WAS CONFIRMED FROM A PHOTOGRAPH PROVIDED BY THE COMPLAINT REPORTER AS THE FEMALE LUER LOCK COMPONENT OF THE PURPLE VALVE WAS SEEN TO BE CRACKED JUST ADJACENT TO THE MOLDED PARTING LINE. THERE WERE NO OTHER VISUAL DEFECTS NOTED TO THE HUB OR CATHETER. A POSSIBLE ROOT CAUSE FOR THE CRACK IS AN OVER-TIGHTENED CONNECTION WITH A MATING MALE LUER (LIKELY A NEEDLELESS CONNECTOR). INADEQUATE FLUSHING OF THE DEVICE MAY ALSO BE A CONTRIBUTING FACTOR. THE DIRECTIONS FOR USE (DFU) SUPPLIED WITH THE REPORTED PICC DEVICE CONTAIN CAUTION THAT "REPEATED OVERTIGHTENING MAY REDUCE HUB CONNECTOR LIFE," AND NOT TO USE HEMOSTATS TO "SECURE OR REMOVE DEVICES WITH LUER LOCK HUB CONNECTIONS." RECOMMENDED FLUSHING TECHNIQUES ARE ALSO STATED IN THE DFU. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A HOME TPN PATIENT EXPERIENCED CRACKING OF AN INDWELLING PICC LINE, REQUIRING REMOVAL. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN FURTHER DETAIL ON THE EVENT. A SAMPLE WAS STATED TO BE AVAILABLE TO BE RETURNED TO ANGIODYNAMICS, HOWEVER IT HAS NOT YET ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174919 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 5209779

    Patients

    Seq Age Sex Outcome Treatment
    1