MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIL,24FR., ROUND HUBLESS FULL FLUTED CHANNEL DRAIN; DRAIN TUBE

Model Number	072234
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 drain tube was too rolled up to use.Per additional received via email on 30 jun 2020 from ibc representative, there was no visible defect and photo samples were attached.
Additional Manufacturer Narrative
The reported event was unconfirmed, as the problem could not be reproduced.The device was not used for treatment.The device met the relevant specifications for the failure.The device was not related to the reported failure as the failure was unconfirmed.Visual evaluation of the returned sample noted one opened (no original packaging), unused silicone channel drain.It was noted that the drain was curled as intended when compared to and noticed without any noticeable kinks, bends or twists along the drain.This meets the specification "ragged cuts in ends, kinks, surfaces with blemishes are not allowed".A potential root cause could not be found since the reported event was unconfirmed.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: "indications: wound drains are used to remove exudates from wound sites.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.
Event or Problem Description
It was reported that the drain tube was too roll up to use.Per additional received via email on 30jun2020 from ibc representative, there was no visible defect and photo samples were attached.Per additional received via email on 30jun2020 from ibc representative, there was no visible defect.

• Brand Name: CHANNEL DRAIL,24FR., ROUND HUBLESS FULL FLUTED CHANNEL DRAIN
• Common Device Name: DRAIN TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10275480
• Report Number: 1018233-2020-04511
• Device Sequence Number: 3854075
• Product Code: GBX
• UDI-Device Identifier: 00801741049927
• UDI-Public: (01)00801741049927
• 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): 10/14/2020

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: 01/31/2024
• Device Model Number: 072234
• Device Catalogue Number: 072234
• Device Lot Number: NGDN1775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1