MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CHANNEL DRAIN

Catalog Number	072225
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the previous issues of channel drain trocars being dull and not draining as effective had stayed persistent and they were looking to convert to cardinal drains because a patient had been harmed.The customer had not yet elaborated on how the patient was harmed or in what way.They spoke with customer to virginia to try to get an understanding of why they were shifting over to cardinal from bard, and they explain that the issues that came into addressed and work on had remained persistent (dull trocars and weak draining) according to the surgeons.It was stated that the patient got hurt due to one of the products, so they have to convert their existing skus.The customer spoke to their coordinator about more information regarding the drain issues.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: note: when using trocar with drain, care should be taken as the sharp and pointed edge of trocar could result in serious injury.After removal of trocar from the drain, please dispose of it as per the hospital protocol in the appropriate biohazard/sharp's container.Instructions for use: the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.Deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.Care must be exercised to avoid damage to the drain (see warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the previous issues of channel drain trocars being dull and not draining as effective had stayed persistent and they were looking to convert to cardinal drains because a patient had been harmed.The customer had not yet elaborated on how the patient was harmed or in what way.They spoke with customer to (b)(6) to try to get an understanding of why they were shifting over to cardinal from bard, and they explain that the issues that came into addressed and work on had remained persistent (dull trocars and weak draining) according to the surgeons.It was stated that the patient got hurt due to one of the products, so they have to convert their existing skus.The customer spoke to their coordinator about more information regarding the drain issues.No medical intervention was reported.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21458816
• Report Number: 1018233-2025-01233
• Device Sequence Number: 7591467
• Product Code: GBX
• UDI-Device Identifier: 00801741049859
• UDI-Public: (01)00801741049859
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Catalogue Number: 072225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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