MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PVC DRAIN WITH TROCAR

Model Number	0080710
Medical Device Problem Codes	Fitting Problem (2183); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: PVC DRAIN WITH TROCAR
• Common Device Name: PVC DRAIN WITH TROCAR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15274639
• Report Number: 1018233-2022-06622
• Device Sequence Number: 6137984
• Product Code: GBX
• UDI-Device Identifier: 00801741050121
• UDI-Public: (01)00801741050121
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0080710
• Device Catalogue Number: 0080710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown