MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PVC DRAIN WITH TROCAR; WOUND DRAIN

Catalog Number	0080700
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	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hospital user found a hair that was sealed in the seal and package for the wound drain.User currently only had the one package that was affected.If needed, they have the package available for qa team.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Complete initial reporter facility 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 hospital user found a hair that was sealed in the seal and package for the wound drain.User currently only had the one package that was affected.If needed, they have the package available for qa team.
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 labeling is found to be adequate.The baw is attached on the investigation overview element.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 the hospital user found a hair that was sealed in the seal and package for the wound drain.User currently only had the one package that was affected.If needed, they have the package available for qa team.Per additional information received via email on 14oct2025, there was no patient involvement.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Capa 12730081 was initiated to address the reported event.Visual evaluation of the returned sample noted one unopened (with original packaging) pvc drain with trocar.Visual inspection noted visible observation of hair inside the packaging and in the seal of the packaging.This does not meet specification per ip7600576, revision 9 which states " no loose or embedded foreign matter larger".This specific complaint allegation was part of a broader investigation captured in capa 12730081.The capa investigation conducted a broader review of labeling, complaints, risk management file, raw materials, and manufacturing changes for this product.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: b, d, e, 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.

• Brand Name: PVC DRAIN WITH TROCAR
• 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: 22530635
• Report Number: 1018233-2025-05926
• Device Sequence Number: 20816354
• Product Code: GBX
• UDI-Device Identifier: 00801741050114
• UDI-Public: (01)00801741050114(11)240728(17)290531(10)NGJT1035
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 11/24/2025

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: 0080700
• Device Lot Number: NGJT1035
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 11/21/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/09/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2024
• 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