BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7192045 · Received January 15, 2018

    Report

    Report Number
    3006948883-2017-00215
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 20, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7083015, EXPIRATION DATE: 03/31/2020, MANUFACTURE DATE: 05/14/2017. MEDICAL DEVICE LOT #: 7110497, EXPIRATION DATE: 04/30/2020, MANUFACTURE DATE: 05/15/2017. INVESTIGATION SUMMARY: A SAMPLE WAS RETURNED FOR INVESTIGATION. THE RETURNED SAMPLE SHOWED THE REPORTED DEFECT. THE COMPLAINT SAMPLE WAS OBSERVED WITH THE EXTENDED TUBING BROKEN IN THE MIDDLE. THE DEFORMATION APPEARS TO BE CAUSED BY THE SLIDE CLAMP. THE OD AND ID THICKNESS WAS MEASURED AND FOUND TO BE IN UNIFORMITY. THE PARTLINE+FLASH DIMENSIONS OF THE SLIDE CLAMP WERE MEASURED, NO ABNORMALITY WAS FOUND. IN ADDITION, NO ABNORMALITY WAS FOUND WHEN CLAMPING TESTS WERE PERFORMED. THE BROKEN EXTUBING BY THE SLIDE CLAMP IS LOWER THAN THE UPPER LIMIT R&D SPECIFIES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS 7083015 AND 7110497. CONCLUSION: THE COMPLAINT MAYBE CAUSED BY THE SLIDE CLAMP DESIGN, THE ANGLE OF THE SLIDE CLAMP OR POSSIBLY THE MATERIAL OF THE EXTEND TUBING MAY HAVE HAD SOME EFFECT ON IT. HOWEVER, NO ABNORMALITIES WERE FOUND IN ALL PARAMETERS OF THE RETURNED SAMPLES. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS FOUND LEAKING ON A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE LEAKAGE WAS FOUND AFTER THE PATIENT HAD BEEN TRANSFERRED TO SURGERY. THE LEAK LOCATED AT THE SLIDE CLAMP AREA AND E-TUBING WAS BROKEN. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35956 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other