BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP

    MDR report key: 8807097 · Received July 19, 2019

    Report

    Report Number
    9617594-2019-00230
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 28, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 LOT, G1, H4. H10: FIVE DEVICES (ONE USED AND FOUR UNUSED) WERE RECEIVED ON 7/18/2019 FOR FURTHER EVALUATION BY THE MANUFACTURER. THE REPORTED PRODUCT PROBLEM FOR SEPARATION AT THE SHUNT/MALE LUER TUBING BOND OF THE CL3534 WAS NOT REPLICATED. HOWEVER, ONE OF THE RETURNED PACKAGED DEVICES DID LEAK AT THE BONDED CONNECTION AND DID NOT MEET THE PRODUCT PERFORMANCE SPECIFICATION FOR THE LEAK TEST. THE BONDED CONNECTION PULL TEST DID MEET THE PRODUCT PERFORMANCE SPECIFICATION TESTING REQUIREMENTS FOR TENSILE STRENGTH SEPARATION. THE PROBABLE CAUSE FOR THE LEAKAGE WAS INSUFFICIENT SOLVENT BOND COVERAGE AT THE BONDED CONNECTION WHICH WAS DUE TO AN ERROR IN THE MANUAL BONDING PROCESS DURING MANUFACTURING. A DEVICE HISTORY REVIEW (DHR) AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION BUT IT HAS NOT YET BEEN RECEIVED. POSSIBLE LOT NUMBERS FOR THE INVOLVED DEVICE INCLUDE 4032844 AND 413439.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC TUBING ON THE DEVICE IS NOT FULLY ATTACHED TO THE BLUE CLOSED SYSTEM TRANSFER DEVICE LEADING TO DETACHMENT AND THE LEAKING OF AN UNKNOWN MEDICATION. THERE WAS PATIENT INVOLVEMENT WITH UNPROTECTED CHEMOTHERAPY EXPOSURE; HOWEVER, NO MEDICATION INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601091 5" (13 CM) APPX 1.8 ML, BAG SPIKE ADAPTER W/CHEMOLOCK¿ W/RED CAP, VENTED CAP CLOSED ANTINEOPLASTIC&HAZARDOUS DRUG RECONSTITUTION&TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CL3534 4113439

    Patients

    Seq Age Sex Outcome Treatment
    1 TAXOL.| TAXOL