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

Catalog Number	V0043610
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/09/2025
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.Initial reporter name: (b)(6) 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 several bd davol cws 400 hemovac drains failed to maintain suction post-operatively at mercy one des moines.In early cases, the tubing was found to be torn near the suction area requiring replacement.More recently, drains showed reduced output and site bulging due to internal blood clots obstructing flow.These issues occurred after or placement and deviated from expected continuous drainage performance.Staff are now documenting incidents, saving devices when possible, and escalating concerns for investigation and support.The events occurred after device placement during post-operative monitoring.No patient-identifiable information is available, but the affected individuals were adult patients of varying ages and genders.None of the incidents resulted in death or serious.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used closed wound suction kit.Visual inspection of the one-photo sample noted that the connector universal-y had bodily fluids stuck inside the connector.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab(s) d and h.(b)(6).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 several bd davol cws 400 hemovac drains failed to maintain suction post-operatively at mercy one des moines.In early cases, the tubing was found to be torn near the suction area requiring replacement.More recently, drains showed reduced output and site bulging due to internal blood clots obstructing flow.These issues occurred after or placement and deviated from expected continuous drainage performance.Staff are now documenting incidents, saving devices when possible, and escalating concerns for investigation and support.The events occurred after device placement during post-operative monitoring.No patient-identifiable information is available, but the affected individuals were adult patients of varying ages and genders.None of the incidents resulted in death or serious.

• 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: 23321666
• Report Number: 1018233-2025-09243
• Device Sequence Number: 18784842
• Product Code: GCY
• UDI-Device Identifier: 00801741051586
• UDI-Public: (01)00801741051586
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/15/2026

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: V0043610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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