BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC DRAIN WITH TROCAR

    MDR report key: 15274639 · Received August 23, 2022

    Report

    Report Number
    1018233-2022-06622
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    July 25, 2022
    Report Date
    December 29, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741050121
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WOUND DRAINS MATERIAL - 0080720, MATERIAL - 0080710 AND MATERIAL - 0070310 DID NOT FIT WITH THE SILICONE EVACUATOR BULBS (MATERIAL - 0070740). CUSTOMER STATED THAT THE FIRST TWO DRAINS (MATERIAL - 0080720, MATERIAL - 0080710) DID NOT COME WITH AN ADAPTOR. THE LAST ONE, MATERIAL - 0070310 HAD AN ADAPTOR BUT DID NOT FIT WITH THE EVACUATOR BULB. PER FOLLOW-UP VIA EMAIL ON 02AUG2022, BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL - 0080710 AND MATERIAL - 0080720 WERE PVC DRAINS THAT WERE NOT CONNECTING. AND STATED THAT THEY WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. THE REPRESENTATIVE ADVISED THAT THE SILICONE DRAIN MATERIAL - 0070310 SHOULD CONNECT WITH SILICONE EVACUATOR MATERIAL - 0070740 SINCE THEY BOTH WERE SILICONE MATERIALS, AND THE CONNECTORS WERE WITHIN THE SILICONE DRAIN PACKAGING. PER ADDITIONAL INFORMATION RECEIVED ON 15AUG2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS (MATERIAL - 0043650). THEY USED JACKSON-PRATT (J/P) DRAINS MORE, AND THOSE WERE THE ONES THEY WERE HAVING ISSUES WITH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WOUND DRAINS MATERIAL - 0080720, MATERIAL - 0080710 AND MATERIAL - 0070310 DID NOT FIT WITH THE SILICONE EVACUATOR BULBS (MATERIAL - 0070740). CUSTOMER STATED THAT THE FIRST TWO DRAINS (MATERIAL - 0080720, MATERIAL - 0080710) DID NOT COME WITH AN ADAPTOR. THE LAST ONE, MATERIAL - 0070310 HAD AN ADAPTOR BUT DID NOT FIT WITH THE EVACUATOR BULB. PER FOLLOW-UP VIA EMAIL ON 02AUG2022, BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL - 0080710 AND MATERIAL - 0080720 WERE PVC DRAINS THAT WERE NOT CONNECTING. AND STATED THAT THEY WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. THE REPRESENTATIVE ADVISED THAT THE SILICONE DRAIN MATERIAL - 0070310 SHOULD CONNECT WITH SILICONE EVACUATOR MATERIAL - 0070740 SINCE THEY BOTH WERE SILICONE MATERIALS, AND THE CONNECTORS WERE WITHIN THE SILICONE DRAIN PACKAGING. PER ADDITIONAL INFORMATION RECEIVED ON 15AUG2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS (MATERIAL - 0043650). THEY USED JACKSON-PRATT (J/P) DRAINS MORE, AND THOSE WERE THE ONES THEY WERE HAVING ISSUES WITH. PER FOLLOW-UP VIA EMAIL ON 14SEP2022, CUSTOMER HAD RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127739 PVC DRAIN WITH TROCAR PVC DRAIN WITH TROCAR GBX C.R. BARD, INC. (COVINGTON) -1018233 0080710 UNK 00801741050121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other