MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED

Model Number	072189
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
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.The device was not returned.
Event or Problem Description
It was reported that the drain was dull so that the surgeon was unable to insert the blake drain without making an incision nger2802 per addition information via email on 13 oct 2020, same issue.No, they were using the drains but struggled to get them in nger0489.
Additional Manufacturer Narrative
The reported event was unconfirmed, as the product meet the specifications.Visual inspection noted 7 unopened channel drains were received with the trocar.Visual evaluation noted no obvious defects.The trocars appeared to be very sharp with no abnormalities.The product was not used for diagnosis or treatment.It was determined that the product had no relationship with the event due to the investigation being unconfirmed through the sample evaluation.The product had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the drain was dull, so the surgeon was unable to insert the blake drain without making an incision.Per additional information received via email on 13oct2020, it was stated that the surgeon used the drains, but struggled during the insertion.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10744917
• Report Number: 1018233-2020-20497
• Device Sequence Number: 3760136
• Product Code: GBX
• UDI-Device Identifier: 00801741049712
• UDI-Public: (01)00801741049712
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 04/30/2025
• Device Model Number: 072189
• Device Catalogue Number: 072189
• Device Lot Number: NGER2802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other