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

Catalog Number	0072430
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
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.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 wound drain was defective.
Event or Problem Description
It was reported that the wound drain was defective.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 hubless silicone flat drain in opened packaging.Verified material number 0072430 and batch number ngjx2125.Visual inspection noted no obvious observations.Using the in-house bulb evacuator the flat drained suction methylene blue solution (3 drops 1percent methylene blue per 100ml distilled water) solution without difficulty.The reported event was not able to be replicated.Risk, labelling, and dhr review was not required as the reported event was unconfirmed.No additional actions can be taken at this time.Correction: d,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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 hubless silicone flat drain in opened packaging.Verified material number 0072430 and batch number ngjx2125.Visual inspection noted no obvious observations.Using the in-house bulb evacuator the flat drained suction methylene blue solution (3 drops 1% methylene blue per 100ml distilled water) solution without difficulty.The reported event was not able to be replicated.Risk, labelling, and dhr review was not required as the reported event was unconfirmed.Corrections made to tab f.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 wound drain was defective.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: WOUND SUCTION
• 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: 22840519
• Report Number: 1018233-2025-06868
• Device Sequence Number: 18536959
• Product Code: GCY
• UDI-Device Identifier: 00801741050022
• UDI-Public: (01)00801741050022(11)241127(17)290930(10)NGJX2125
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,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: 0072430
• Device Lot Number: NGJX2125
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 03/27/2026; 04/15/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 03/30/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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