MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 10MM FLAT FULL FLUTED WITH 4.7MM TROCAR

Model Number	072215
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2020
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.
Event or Problem Description
It was reported that the customer notified a piece of jp tubing from bulb drain appears to be separated from the drain tubing inside the patient and was retained for a month after drain removal.
Event or Problem Description
It was reported that the customer notified that the piece of jp tubing from bulb drain appears to be separated from the drain tubing inside the patient and was retained for a month after drain removal.
Additional Manufacturer Narrative
The reported issue was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "tensile requirements are not appropriate for the type of drain and/or procedure".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: "· avoid suturing through drains.· drains should lie flat and in line with the skin exit areas.· particular care should be taken to avoid any obstacles to the drain exit path.· drains should be checked for free motion during closure to minimize the possibility of breakage.· drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.· surgical removal may be necessary if drain is difficult to remove or breaks"." corrections: h 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.H3 other text : the device was not returned.

• Brand Name: CHANNEL DRAIN, 10MM FLAT FULL FLUTED WITH 4.7MM TROCAR
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11716064
• Report Number: 1018233-2021-02341
• Device Sequence Number: 4244879
• Product Code: GBX
• UDI-Device Identifier: 00801741049804
• UDI-Public: (01)00801741049804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 02/29/2024
• Device Model Number: 072215
• Device Catalogue Number: 072215
• Device Lot Number: NGDP2772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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