MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CHANNEL DRAIN

Catalog Number	072214
Medical Device Problem Codes	Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an additional complaints have been reported regarding the same item, and it has been identified that the issue may affect multiple items beyond the originally reported 072221.A meeting is requested to discuss the issue further.Consideration is being given to removing the affected product and related items from inventory until confirmation of resolution is obtained.Impacted items include: 072211, 072190, 072189, 072214, 072186.Additional reports dated august 11 from the customer are included below.Communication from august 7 was submitted and documented with customer outreach pending.New reports should be reviewed to confirm alignment with previously opened records.Ensure inclusion of bd customer quality and relevant stakeholders in all customer communications.
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 an additional complaints have been reported regarding the same item, and it has been identified that the issue may affect multiple items beyond the originally reported 072221.A meeting is requested to discuss the issue further.Consideration is being given to removing the affected product and related items from inventory until confirmation of resolution is obtained.Impacted items include: 072211.072190.072189.072214.072186.Additional reports dated (b)(6) from the customer are included below.Communication from (b)(6) was submitted and documented under pr (b)(4) and (b)(4), with customer outreach pending.New reports should be reviewed to confirm alignment with previously opened records.Ensure inclusion of bd customer quality and relevant stakeholders in all customer communications.Per additional information received via email on 14aug2025, it was reported that they shared clinicians raised multiple concerns related to item 072221 and then inspected similar items at their distribution center and found fuzzy hair foreign matter in those items as well.There was no harm to a patient as these were found before use.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 1 unopened channel drain.Upon opening packaging, dust particles were present on the channel drain.Therefore, the reported event is confirmed and does not meet specifications per (b)(4) which states "product must be clean and free from oil or grease or loose foreign matter in excess of an aggregate total of 0.6mm² per tappi dirt estimation chart or 1/16in.In length." labelling review is not required as labelling would not have prevented the reported event.Dhr review did not show any problems or conditions that would have contributed to the reported event.Correction -b, 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.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL 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: 22816273
• Report Number: 1018233-2025-06804
• Device Sequence Number: 18395710
• Product Code: GBX
• UDI-Device Identifier: 00801741049798
• UDI-Public: (01)00801741049798(11)250210(17)291231(10)NGKN1625
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/28/2025

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: 072214
• Device Lot Number: NGKN1625
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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