BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN.

    MDR report key: 6083061 · Received November 7, 2016

    Report

    Report Number
    3006948883-2016-00029
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6082043, MEDICAL DEVICE EXPIRATION DATE: 3/31/2019, DEVICE MANUFACTURE DATE: 3/21/2016. MEDICAL DEVICE LOT #: 5326312, MEDICAL DEVICE EXPIRATION DATE: 11/30/2018, DEVICE MANUFACTURE DATE: 11/22/2016. RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A MICROSCOPIC INSPECTION REVEALED THE CATHETER HAD BROKEN AT 10MM FROM THE CATHETER ADAPTER AND THERE WAS EVIDENCE OF PULLING AT THE BREAK. A SIMULATED USE TEST WAS CONDUCTED BY PIERCING A CATHETER AND GENTLY PULLING AND THE BROKEN SECTION OF THE CATHETER USED IN THE SIMULATION APPEARED SIMILAR TO THAT OF THE RETURNED SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE POTENTIAL LOT NUMBERS, 6082043 AND 5326312, REVEALED NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. A MANUFACTURING REVIEW FOUND NO ABNORMALITIES IN THE INCOMING MATERIAL, THE ASSEMBLY PROCESS, OR THE PACKAGING PROCESS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ADDITIONALLY, ACCORDING TO FEEDBACK FROM CUSTOMER, REINSERTION EXISTED DURING CUSTOMER OPERATION WHICH MAY HAVE CAUSED THE CATHETER TO BREAK AFTER PULLING IT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN. BROKE DURING INSERTION INTO A PATIENT'S HAND. THERE WAS NO FLASHBACK WHEN THE NURSE ATTEMPTED TO INSERT THE IV AND THE NURSE TRIED TO REINSERT THE SAME CANNULA. THE CATHETER WAS OBSERVED TO HAVE BROKEN WHEN IT WAS REMOVED THE SECOND TIME. THE PATIENT RECEIVED AN X-RAY AND A CT SCAN AND THE BROKEN CATHETER WAS CONFIRMED TO BE IN THE PATIENT'S INSERTION SITE. LATER THE SAME AFTERNOON, THE PATIENT HAD A SUCCESSFUL SURGERY TO REMOVE THE BROKEN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732376 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN. INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention