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

Catalog Number	5552003
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was not returned for evaluation, as such we are unable to review for root cause determination.Additional information has been requested.Based on not having the sample returned to evaluate, no conclusion can be made.Note, the medical device lot # provided in is one of three potential lots (juep2205/ juet3041/ judvf008) used by the distributor (b)(4)" to provide the kit product to the customer.Lot no: juep2205; release date: 03/25/2020; lot expiration date: 02/28/2023; qty: (b)(4).Lot no: juet3041; release date: 07/23/2020; lot expiration date: 06/28/2023; qty: (b)(4).Lot no: judvf008; release date: 08/27/2019; lot expiration date: 07/28/2022; qty: (b)(4).Review of manufacturing records indicate that all lots were manufactured to specification.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021, the suction tip of the bard/davol x-stream laparoscopic irrigation tubing set with nezhat-dorsey trumpet valve fell off and irrigation fluid leaked.There was no reported patient injury.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11257531
• Report Number: 1213643-2021-20015
• Device Sequence Number: 11441324
• Product Code: GCJ
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 02/28/2023
• Device Catalogue Number: 5552003
• Device Lot Number: JUEP2205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/01/2021
• 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