BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

    MDR report key: 10067088 · Received May 18, 2020

    Report

    Report Number
    3006948883-2020-00190
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 27, 2020
    Report Date
    June 22, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141583. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. BASED ON THE PROVIDED PHOTOGRAPH AND A REVIEW OF THE ON-SITE MANUFACTURING PROCESSES OUR QUALITY ENGINEERS HAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO A MILD DEFORMATION IN THE CATHETER ADAPTER. DEFORMATIONS SUCH AS THESE ARE CURRENTLY MONITORED USING AN AUTOMATED VISION INSPECTION SYSTEM. ADDITIONALLY A REVIEW OF AVAILABLE RETENTION SAMPLES WERE UNABLE TO IDENTIFY ANY ADDITIONAL INSTANCES OF THIS FAILURE MODE. IN ORDER TO MITIGATE FUTURE OCCURRENCES OF THIS EVENT OUR FACILITY HAVE OPTIMIZED THE VISION INSPECTION SYSTEM FOR THE CATHETER ADAPTER POSITION CHECK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 17 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC SAFETY SHIELDS FAILED TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE IN THE SURGERY ANESTHESIA DEPARTMENT OF HENAN UNIVERSITY FIRST AFFILIATED HOSPITAL OF TRADITIONAL CHINESE MEDICINE HAD GIVEN FEEDBACK WITH THE NEEDLE. DURING GIVING PUNCTURING FOR PATIENT , SAFETY SHIELD WAS IMMEDIATELY FLIPPED OUT WHEN THE NURSE WAS RETREATING THE NEEDLE, AND IT DID NOT ACTIVATE. ACCORDING TO THE NURSE'S FEEDBACK, THE NEEDLE HAD APPEARED SIMILAR CASES IN THIS MONTH, THERE WERE 17 NEEDLES WITH THE SAME SITUATION ON THE BATCH. COMPARED WITH THE SAME BATCH BEFORE, NURSES WERE FEELING SIGNIFICANTLY BLUNT DURING PUNTURING, THE HEAD NURSE HAD ASKED TO REMAIN THE SAMPLE, AND SHE ALSO CONTACTED BD EMPLOYEES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC SAFETY SHIELDS FAILED TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE IN THE SURGERY ANESTHESIA DEPARTMENT OF (B)(6) FIRST AFFILIATED HOSPITAL OF TRADITIONAL (B)(6) MEDICINE HAD GIVEN FEEDBACK WITH THE NEEDLE. DURING GIVING PUNCTURING FOR PATIENT, SAFETY SHIELD WAS IMMEDIATELY FLIPPED OUT WHEN THE NURSE WAS RETREATING THE NEEDLE, AND IT DID NOT ACTIVATE. ACCORDING TO THE NURSE'S FEEDBACK, THE NEEDLE HAD APPEARED SIMILAR CASES IN THIS MONTH, THERE WERE 17 NEEDLES WITH THE SAME SITUATION ON THE BATCH. COMPARED WITH THE SAME BATCH BEFORE, NURSES WERE FEELING SIGNIFICANTLY BLUNT DURING PUNCTURING, THE HEAD NURSE HAD ASKED TO REMAIN THE SAMPLE, AND SHE ALSO CONTACTED BD EMPLOYEES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531859 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9262026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other