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

Catalog Number	0070740
Medical Device Problem Codes	Partial Blockage (1065); Disconnection (1171)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient arrived in clinic this morning after speaking to a triage nurse regarding her drain.Patient stated she called our triage line at 230am regarding her drain not draining and then once she stripped the line a couple times, something came off in the bulb.She was told by the nurse to come into the clinic this morning.Brought patient back to check her drain.On exam, the suction valve on the inside of the bulb had popped off and was at the bottom of the bulb.It looks like there was some tissue debris that got stuck the in-suction valve which had blocked the drain from draining properly.Emptied bulb and replaced it with a new one.I told the patient that if anything happens over the weekend to call triage and just ask for the on-call breast surgeon.
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.The reported event is addressed within the labeling.This occurrence does not introduce a new hazard or harm.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: d,e,f,h.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 patient arrived in clinic this morning after speaking to a triage nurse regarding her drain.Patient stated she called our triage line at 230am regarding her drain not draining and then once she stripped the line a couple times, something came off in the bulb.She was told by the nurse to come into the clinic this morning.Brought patient back to check her drain.On exam, the suction valve on the inside of the bulb had popped off and was at the bottom of the bulb.It looks like there was some tissue debris that got stuck the in-suction valve which had blocked the drain from draining properly.Emptied bulb and replaced it with a new one.I told the patient that if anything happens over the weekend to call triage and just ask for the on-call breast surgeon.

• 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: 23115754
• Report Number: 1018233-2025-08447
• Device Sequence Number: 20770781
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0070740
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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