MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED; BARD SILICONE CHANNEL DRAIN

Model Number	072217
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	09/13/2021
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.
Event or Problem Description
It was reported that there was a hair found mixed in the package of the bard channel drain.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device has not met specifications.The product was not used for patient treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), channel drain.Visual inspection of the sample noted a piece of hair found in the sealed packaging.A potential root cause for this failure could be defective / contaminated components from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that there was hair found mixed in the package of bard channel drain.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED
• Common Device Name: BARD SILICONE CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12605304
• Report Number: 1018233-2021-06296
• Device Sequence Number: 12539767
• Product Code: GBX
• UDI-Device Identifier: 00801741049828
• UDI-Public: (01)00801741049828
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Expiration Date: 02/27/2026
• Device Model Number: 072217
• Device Catalogue Number: 072217
• Device Lot Number: NGFP5149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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