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

Model Number 0043650

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: PVC DRAIN WITH TROCAR
• Type of Device: WOUND DRAIN
• 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: 15293694
• MDR Text Key: 305423195
• Report Number: 1018233-2022-06665
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049385
• UDI-Public: (01)00801741049385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0043650
• Device Catalogue Number: 0043650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other