BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC

    MDR report key: 19067948 · Received April 8, 2024

    Report

    Report Number
    3013666218-2024-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 8, 2024
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K072391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DEVICE HISTORY RECORD (DHR): FINISHED GOOD: PFM2CT4DN. LOT NUMBER: 2306-048. RELEASED DATE: 07/26/2023. EXPIRATION DATE: 04/28/2025. MANUFACTURED DATE: 06/22/2023. QUANTITY: (B)(4). COMPONENT ATTRIBUTED TO THE COMPLAINT: R3-0152-01 4F X 50CM DUAL LUMEN PFM PICC CATHETER THE COMPONENT INSPECTION RECORDS WERE REVIEWED AND FOUND TO BE IN ORDER. THE LOT HAS BEEN DEPLETED IN THE INVENTORY REVIEW OF COMPLAINTS LOG (YEAR 2021-CURRENT): (B)(4)SIMILAR COMPLAINTS OF LUER CONNECTOR CRACKS/LEAK HAVE BEEN IDENTIFIED. REVIEW OF NCR'S AND CAPA'S (2021- CURRENT): NO CAPA OR NCR HAS BEEN RECORDED THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT TOTAL SALES OF PICC PRODUCT FROM 2017-2024 = (B)(4) OCCURRENCE RATE = (B)(4) REVIEW OF RISK ANALYSIS: THE RISK IS IDENTIFIED WITHIN THE RISK ANALYSIS. RSK-00127-02-AE INDEX 63 "PROLONGED PROCEDURE/DELAY IN TREATMENT/ REPLACE CATHETER": "HUB CRACK (LEAK): DAMAGE, EXCEED TORQUE LIMITS OF LUER, IMPROPER USE OF CHEMICALS TO CLEAN THE HUB"; PROBABILITY OF OCCURRENCE: (B)(4) CURRENT OCCURRENCE RATE: (B)(4) THE OCCURRENCE RATE IS WITHIN THE ACCEPTABLE FREQUENCY RATE AS OUTLINED IN THE RISK ANALYSIS. RETAIN SAMPLE EVALUATION: LEAK TESTING: LEAK TEST WAS PERFORMED FOR BOTH CLEAR AND PURPLE LUER CONNECTORS OF THE RETAIN SAMPLE FROM THE SAME LOT. CLEAR LUER CONNECTOR: NO LEAK WAS OBSERVED AFTER APPLYING 90PSIG FOR A MINIMUM OF 15 SECONDS. PURPLE LUER CONNECTOR: NO LEAK WAS OBSERVED AFTER APPLYING 90PSIG FOR A MINIMUM OF 15 SECONDS. RETAIN SAMPLE ADDITIONAL TESTING: THE NEEDLE-FREE VALVE WAS REPEATEDLY CONNECTED WITH CONSIDERABLE FORCE TO THE LUER CONNECTOR, AND NO SIGNS OF CRACKING WERE OBSERVED THEREAFTER. RETAIN AND RETURNED SAMPLE COMPARISON: PHYSICAL COMPARISON OF THE RETAIN AND RETURNED SAMPLE SHOWED THAT THE PFM MEDICAL INC. SUPPLIED NEEDLE-FREE VALVE IS SIGNIFICANTLY BIGGER THAT THE COMPETITOR VALVE. RETURNED SAMPLE EVALUATION: THE SAMPLES FOR (B)(4) ARRIVED TOGETHER IN A SINGLE PACKAGE, LABELED AS 1 AND 2, RESPECTIVELY. RETURNED SAMPLE VISUAL INSPECTION: THE REPORTED COMPETITOR VALVES, BD MAXZERO ((B)(6)) NEEDLE-FREE VALVE (LABELED AS "LABEL1") IS CONNECTED TO THE CLEAR LUER CONNECTOR, WHEREAS THE ICU MEDICAL NEEDLE-FREE CONNECTOR (LABELED AS "LABEL2") REMAINS AFFIXED TO THE PURPLE CONNECTOR. RETURNED SAMPLE LEAK TESTING: LEAK TESTING WAS CONDUCTED FOR BOTH THE CLEAR AND PURPLE LUER CONNECTORS OF THE RETURNED SAMPLE (LABEL1) . UPON CONNECTING THE CLEAR LUER CONNECTOR AND APPLYING PRESSURE, AN IMMEDIATE LEAK WAS OBSERVED, CONFIRMING THE REPORTED ISSUE, WHILE THE PURPLE CONNECTOR SHOWED NO EVIDENCE OF LEAKAGE. ROOT CAUSE ANALYSIS: FOLLOWING THE COMPLETION OF THE RETAIN AND RETURN SAMPLE ASSESSMENT, THE ROOT CAUSE OF THE ISSUE CANNOT BE ESTABLISHED AT THIS TIME. IT IS POSSIBLE THAT THE REPEAT OVER-TIGHTENING OF THE CONNECTION COULD BE THE CAUSE OF THE PROBLEM, HOWEVER,THIS COULD NOT BE CONFIRMED. CONCLUSION: THE RETURNED SAMPLE UNDERWENT THOROUGH VERIFICATION AND INVESTIGATION. UPON INSPECTION, IT WAS OBSERVED THAT THE NEEDLE-FREE VALVE UTILIZED DURING INFUSION WAS IDENTIFIED AS A COMPETITOR'S VALVE, DIFFERING FROM THE ONE ORIGINALLY SUPPLIED. SUBSEQUENT LEAK TESTING CONFIRMED THE REPORTED LEAKAGE. HOWEVER, EVALUATION OF THE RETAINED SAMPLE FROM THE SAME LOT REVEALED NO DEVIATIONS. FOLLOWING THE ANALYSIS, IT IS SUSPECTED THAT OVER-TIGHTENING OF THE CONNECTION COULD BE THE CAUSE OF THE REPORTED CRACKING OF THE CONNECTOR. AS PER THE INSTRUCTIONS FOR USE (IFU): 'REPEATED OVER-TIGHTENING OF LUER LOCK CONNECTIONS, SYRINGES, AND CAPS WILL REDUCE CONNECTOR LIFE AND COULD LEAD TO POTENTIAL CONNECTOR FAILURE.' ADDITIONALLY, THE IFU SUGGESTS THAT REPEATED OR PROLONGED EXPOSURE TO ALCOHOL OR ALCOHOL-CONTAINING ANTISEPTICS COULD DEGRADE THE CATHETER. THE ISSUE DOES NOT POSE A RISK TO THE PATIENT AND COULD ONLY RESULT IN TREATMENT DELAY. THE RISK HAS BEEN IDENTIFIED WITHIN THE RISK ANALYSIS, AND THE OCCURRENCE RATE IS BELOW THE ACCEPTABLE FREQUENCY RATE AS OUTLINED IN THE RISK ANALYSIS DOCUMENT.

    Description of Event or Problem · 0

    AFTER NEEDLELESS CONNECTOR CHANGED, RN NOTED INFUSATE LEAKING AT LUER LOCK CONNECTION. VASCULAR ACCESS RN AT BEDSIDE TO ASSESS, LINEAR CRACK VISUALIZED ON CLEAR LUMEN OF CATHETER. PICC EXCHANGED PERFORMED. 2 OF THE MOST RECENT CATHETERS THAT HAVE CRACKED: IT IS A LINEAR CRACK DOWN THE LUMEN. MEDICAL INTERVENTION REQUIRED TO REPLACE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608013 PICC 4F X 50CM DUAL LUMEN CT PICC LJS PFM MEDICAL, INC. PFM2CT4D 2306-048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other