MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR; WOUND DRAIN

Catalog Number 0043630

Device Problem Disconnection (1171)

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

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the tube came apart at 2 different sites.

Event Description

It was reported that the tube came apart at 2 different sites.Per follow up information received on 03nov2020, stated that the product inserted in the or and the patient came to the nursing unit with the hemovac in place and was unable to collect the contaminated drains to send.The patient impact was undetermined due to the reported events and had to cross reference the field reports with po infections due to the break in portal.Also had an event for an rn ¿ splashing of blood product and to tape the site where the tubing was connected-efficiently.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: b, 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.The device was not returned.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10693171
• MDR Text Key: 213504311
• Report Number: 1018233-2020-20194
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2023
• Device Catalogue Number: 0043630
• Device Lot Number: NGCT2563
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other