BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC DRAIN WITH TROCAR

    MDR report key: 15293694 · Received August 25, 2022

    Report

    Report Number
    1018233-2022-06665
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 15, 2022
    Report Date
    November 7, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741049385
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WOUND DRAIN MATERIAL# 0080720, MATERIAL# 0080710 AND MATERIAL# 0070310 DID NOT FIT WITH SILICONE EVACUATOR BULBS (MATERIAL# 0070740). CUSTOMER STATED THAT 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 (B)(6) 2022 , BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL# 0080710 AND MATERIAL# 0080720 WERE PVC DRAINS AND ADVISED THAT THOSE WERE NOT CONNECTING BECAUSE THOSE WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. REPRESENTATIVE ADVISED THAT 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 15-AUG-2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16-AUG-2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS. 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 WOUND DRAIN MATERIAL# 0080720, MATERIAL# 0080710 AND MATERIAL# 0070310 DID NOT FIT WITH SILICONE EVACUATOR BULBS (MATERIAL# 0070740). CUSTOMER STATED THAT 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 02-AUG-2022, BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL# 0080710 AND MATERIAL# 0080720 WERE PVC DRAINS AND ADVISED THAT THOSE WERE NOT CONNECTING BECAUSE THOSE WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. REPRESENTATIVE ADVISED THAT 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 15-AUG-2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16-AUG-2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS. 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
    2681515 PVC DRAIN WITH TROCAR WOUND DRAIN GCY C.R. BARD, INC. (COVINGTON) -1018233 0043650 UNK 00801741049385

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other