MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR

Catalog Number 072227

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the channel drain comes off easily, this was not usually the case.Per additional information from the ibc via email on 22aug2019, the disconnection was occurring between the wound drain tube and the evacuator.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used (note yellowing of inlet port and biological matter throughout assembly) silicone bulb evacuator with a connected drainage tube.Visual inspection of the sample noted no obvious visible defects.The channel drain seemed firmly connected to the inlet port of the adapter on the evacuator assembly.Excessive force was applied to the drain tubing and the drain did not separate from the adapter on the evacuator assembly.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to avoid the possibility of drain damage or breakage: · 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.Drain placement · the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.· tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.· positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.· drain tubing should be placed within the wound by approximating the areas of critical fluid collection.· care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.· taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.· deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.· care must be exercised to avoid damage to the drain (see warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician." 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 Description

It was reported that the channel drain comes off easily, this was not usually the case.Per additional information from the ibc via email on (b)(6)2019 , the disconnection was occurring between the wound drain tube and the evacuator.

• Brand Name: CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR
• Type of Device: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8959496
• MDR Text Key: 159842891
• Report Number: 1018233-2019-05306
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049873
• UDI-Public: (01)00801741049873
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 09/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1