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

Catalog Number	072217
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
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 the user found a foreign material on the backside of the inner pouch when the outer package was opened.
Event or Problem Description
It was reported that the user found a foreign material on the backside of the inner pouch when the outer package was opened.
Additional Manufacturer Narrative
The reported event was confirmed.The device had not met specifications, and the product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (inside original packaging), bard silicone channel drain package.The outer packaging was opened, but the inner packaging containing the drain remained sealed.Visual inspection of the sample noted a piece of foreign material measuring 0.2805 inches taped to the exterior of the inner packaging.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: an effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir suction must be maintained in order for the system to function properly.Verify that the system is functioning properly.If the system is not maintained properly, surgical complications, including hematomas, may result." 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.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9495665
• Report Number: 1018233-2019-08086
• Device Sequence Number: 19438692
• 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: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 02/29/2024
• Device Catalogue Number: 072217
• Device Lot Number: NGDP2763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/19/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1