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

Catalog Number	0070740
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	08/22/2025
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 customer was received one package of wound drain product ref # (b)(4) with a hair packaged inside with product.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Capa 6378919 was initiated to address the reported event.Received (1) photo samples.Visual inspection of the one-photo sample noted a strand of hair on the silicone suction bulb inside the unopen packaging.Visual evaluation of the returned sample noted one unopened (without original packaging), silicone closed wound suction evacuator.Visual inspection of the sample noted a strand of hair on the silicone suction bulb inside the unopen packaging.This does not meet specification which states "the product/assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc." this specific complaint allegation was part of a broader investigation captured in capa 6378919.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.Correction: d.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.
Event or Problem Description
It was reported that the customer was received one package of wound drain product ref # (b)(4) with a hair packaged inside with product.
Event or Problem Description
It was reported that the customer was received one package of wound drain product ref # (b)(4) with a hair packaged inside with product.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Capa 6378919 was initiated to address the reported event.Visual evaluation of the returned one-photo sample noted one opened (with original packaging), silicone evacuators wound drain.Visual inspection of the one-photo sample noted a strand of hair on the silicone suction bulb inside the unopen packaging.This does not 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.".This specific complaint allegation was part of a broader investigation captured in capa 6378919.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: d, e, 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: 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: 22895801
• Report Number: 1018233-2025-07083
• Device Sequence Number: 5916253
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569(17)290831(10)NGJW0297
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 0070740
• Device Lot Number: NGJW0297
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 11/12/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/31/2025; 11/18/2025
• 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