MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM TUBING SETS; LAPAROSCOPIC, GENERAL & PLASTIC SURGERY

Catalog Number	5552001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the leakage in x-stream tubing set w/ nd smokevac trumpet valve laparoscopic irrigation system.The sample has not been returned for evaluation at this time.Based on the information provided and without having the sample for evaluation, no conclusion can be made.This mdr was submitted to represent the bard/davol x-stream tubing set (device #1).An additional mdr was submitted to represent the bard/davol x-stream tubing set (device #2) should additional information be provided and/or the sample is returned, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
As reported, on (b)(6) 2020 during the installation of sterile water in x-stream tubing set w/ nd smokevac trumpet valve, there was leakage in the tubing set at the bottom of the cassette.The event happened twice.There was no reported patient injury but there was a delay in starting the procedure.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11027580
• Report Number: 1213643-2020-20084
• Device Sequence Number: 668787
• Product Code: GCJ
• UDI-Device Identifier: 00801741010088
• UDI-Public: (01)00801741010088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 06/28/2023
• Device Catalogue Number: 5552001
• Device Lot Number: JUET3056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other