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

Catalog Number	0071430
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer found some excess plastic on the tube of an individual item of evacuator.On the tubing portion of the drain there were small pieces of plastic that were adhered to the tubing but sloughed off easily.Product was discarded; a new one was opened with no issues.Spoke with customer about this issue and only found on a single item so far in the or that day, they were going with most likely a one off however since they could not check through the packaging the or staff will be instructed to inspect the item once removed from the packaging for debris, set aside the product, and report it if found for follow up.Sample is available and was with them.
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 confirmed -manufacturing related.Received 1 suction evacuator in opened packaging.Verified material number 0071430 and batch number ngkq0146.Visual inspection noted foreign material and excess silicone inside the packaging.This does meet specification per (b)(4), revision 12 which states "the product/assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc." the labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,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 customer found some excess plastic on the tube of an individual item of evacuator.On the tubing portion of the drain there were small pieces of plastic that were adhered to the tubing but sloughed off easily.Product was discarded; a new one was opened with no issues.Spoke with customer about this issue and only found on a single item so far in the or that day, they were going with most likely a one off however since they could not check through the packaging the or staff will be instructed to inspect the item once removed from the packaging for debris, set aside the product, and report it if found for follow up.Sample is available and was with them.

• 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: 22772223
• Report Number: 1018233-2025-06661
• Device Sequence Number: 18463886
• Product Code: GCY
• UDI-Device Identifier: 00801741049668
• UDI-Public: (01)00801741049668(11)250413(17)300228(10)NGKQ0146
• 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
• Report Date (Section B): 01/30/2026

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: 0071430
• Device Lot Number: NGKQ0146
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2025
• 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