MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT; TROCAR

Model Number	V0043610
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2021
Type of Reportable Event	Serious Injury
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 patient underwent a total knee replacement few days back.It was stated that a hemovac drain was placed in the wound to facilitate drainage and on the day of drainage, the nurse went to remove the drain and met some resistance but was able to pull the drain.However, upon inspection of the drain post removal it was found that the drain to be incomplete in length and an x-ray was taken and found a portion of the drain had broken off inside the operative site and was retained.Stated that after a couple of days, the patient was taken back to surgery for removal of the retained portion.The retained drain piece measured 4 by 0.2 by 0.2 cm in length.Patient would be monitored for possible post operation infection.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿drain was manufactured incorrectly (dimensions or material out spec, curing time not appropriate, etc.)".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, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.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.
Event or Problem Description
It was reported that the patient underwent a total knee replacement few days back.It was stated that a hemovac drain was placed in the wound to facilitate drainage and on the day of drainage, the nurse went to remove the drain and met some resistance but was able to pull the drain.However, upon inspection of the drain post removal it was found that the drain to be incomplete in length and an x-ray was taken and found a portion of the drain had broken off inside the operative site and was retained.Stated that after a couple of days, the patient was taken back to surgery for removal of the retained portion.The retained drain piece measured 4 by 0.2 by 0.2 cm in length.Patient would be monitored for possible post operation infection.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT
• Common Device Name: TROCAR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13480845
• Report Number: 1018233-2022-00472
• Device Sequence Number: 14793456
• Product Code: GCY
• UDI-Device Identifier: 00801741051586
• UDI-Public: (01)00801741051586
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: V0043610
• Device Catalogue Number: V0043610
• Device Lot Number: NGFV0826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 267 KG
• Patient Race: White