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

Catalog Number	5552002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the x-stream laparoscopic irrigation tubing set is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2020.Note, the date of event provided is based on a best estimate on the date of awareness of the reported event.If/when the sample is received and evaluated or additional information is provided, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that, the x-stream laparoscopic irrigation tubing set with nezhat-dorsey trumpet valve 5 mm x 33 cm leaked irrigation fluid during an unknown procedure.Another device was used to complete the procedure.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: 10822669
• Report Number: 1213643-2020-20041
• Device Sequence Number: 11702426
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 5552002
• Device Lot Number: JUEU8003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/11/2020
• 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
• Patient Age: 33 YR