MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Channel Drain; Wound Drain

Catalog Number	072223
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
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: sections 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 image quality was poor before use, despite the presence of an x-ray opaque line.For batch no.Ngks3120, ngkt2584, and for ngku1447 batch no.Per follow up information received via ibc on 18 feb 2026, stated that multiple instances occurred where poor imaging was observed during patient use of this product, despite the presence of radiopaque lines exact occurrence dates and specific quantities unknown.Additionally, poor imaging was observed in several products not only in urology but also in other departments surgery.Therefore, since there was no trust in the current hospital inventory of this lot, request a recall and investigation of all units.For the 3 lots (13 units) being returned this time, it is unknown whether they are the actual units where the appropriate action was taken.Lot: ngks3120, ngkt2584, ngku1447.

• Brand Name: Channel Drain
• Common Device Name: Wound 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 ; +1(770)784-6100
• MDR Report Key: 24422019
• Report Number: 1018233-2026-01149
• Device Sequence Number: 10570011
• Product Code: GBX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2026

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: 072223
• Device Lot Number: NGKS3120
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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