BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND DRAINAGE

    MDR report key: 15416938 · Received September 14, 2022

    Report

    Report Number
    1018233-2022-07088
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 16, 2022
    Report Date
    November 11, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GCY
    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

    PER ADDITIONAL INFORMATION RECEIVED, BD HAS BEEN 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. AS PER FOLLOW-UP VIA EMAIL ON 02AUG2022, 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. AS 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. AS PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, 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 (MATERIAL# UNK ).

    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. AS PER FOLLOW-UP VIA EMAIL ON 02AUG2022, 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. AS 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. AS 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 (MATERIAL# UNK). AS PER FOLLOW-UP VIA EMAIL ON 14SEP2022, CUSTOMER HAD RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622387 WOUND DRAINAGE WOUND DRAINAGE GCY C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other