MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION; WOUND DRAIN

Catalog Number	0043610
Medical Device Problem Codes	Collapse (1099); Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a closed spine surgery, the team had to go through three different drains for one patient because the drains were not functioning properly.Each wound drain kept closing or collapsing.When a drain was not working as intended, blood and fluid can build up instead of been removed.That can lead to a hematoma, which increases the risk of infection, especially in a surgical setting.Per additional information received an email on 27jan2026 stated that phone call from the neuro/spine coordinator at adventhealth tampa, who shared further details about the issue and explained that the problem they experienced with item #0043610 ¿ evac 400cc-3 spring 1/8 was that the three-spring evacuator was not functioning properly.The evacuator would not stay compressed, which prevented the drain from working as intended.It would not maintain a proper seal and that's why they tried using 3 different drains.And also mentioned that they were able to locate the drains in the bin afterward; however, because the original wrapper was not saved, they cannot confirm with certainty which unit was used or the associated lot number.
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.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.An investigation was not completed because the event has been determined to be cascading.Corrections: f, h.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 during a closed spine surgery, the team had to go through three different drains for one patient because the drains were not functioning properly.Each wound drain kept closing or collapsing.When a drain was not working as intended, blood and fluid can build up instead of been removed.That can lead to a hematoma, which increases the risk of infection, especially in a surgical setting.Per additional information received an email on 27jan2026 stated that phone call from the neuro spine coordinator at adventhealth tampa, who shared further details about the issue and explained that the problem they experienced with item 0043610 evac 400cc 3 spring 1/8 was that the three spring evacuator was not functioning properly.The evacuator would not stay compressed, which prevented the drain from working as intended.It would not maintain a proper seal and that's why they tried using 3 different drains.And also mentioned that they were able to locate the drains in the bin afterward; however, because the original wrapper was not saved, they cannot confirm with certainty which unit was used or the associated lot number.

• Brand Name: CLOSED WOUND SUCTION
• 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 ; 7707846100
• MDR Report Key: 24223859
• Report Number: 1018233-2026-00483
• Device Sequence Number: 9366953
• Product Code: GCY
• UDI-Device Identifier: 00801741049354
• UDI-Public: (01)00801741049354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 0043610
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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