MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN,15FR.,ROUND,HUBLESS ONE-PIECE CHANNEL DRAIN; WOUND DRAIN

Catalog Number 072228

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2020

Event Type  Injury  

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 there was an issue with bard channel drain.Additional information required.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 there was an issue with bard channel drain.Per medwatch complaint on (b)(6) 2020, it was reported that the ortho placed bard channel drain 15 fe round hubless full fluted drain after total knee replacement.When gently pulling drain out, it snapped off leaving part in patient.The piece had to be removed from patient by reopening the wound.

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: "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".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.

Event Description

It was reported that there was an issue with bard channel drain.Per medwatch complaint on 16nov2020,it was reported that the ortho placed bard channel drain 15 fe round hubless full fluted drain after total knee replacement.When gently pulling drain out, snapped off, leaving part in patient.The piece had to be removed from patient by reopening the wound.

• Brand Name: CHANNEL DRAIN,15FR.,ROUND,HUBLESS ONE-PIECE CHANNEL DRAIN
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10842637
• MDR Text Key: 216324440
• Report Number: 1018233-2020-20966
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072228
• Device Lot Number: NGES2387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention