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

Catalog Number	5552002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.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) released for distribution in july, 2020.When the investigation has been completed, a supplemental emdr will be submitted.
Event or Problem Description
As reported per maude event report (mw5096517): "the x-stream tubing set w/ nd trumpet valve was checked by biomed on 04-sep-2020 and found no issues." addendum per additional information: it was reported, during set up of a procedure, during the priming of the x-stream tubing set, it was noted that there was leaking of the saline irrigation fluid from the bottom of the cassette/housing chamber.The or staff removed the tubing set, used another set in the same controller without any issues.There was no patient involvement.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1800 units released for distribution in july, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of device evaluation.The subject product was returned for evaluation and confirmed for a fluid leak.Fluid has entered the motor housing going beyond the lip seal of the motor mount and into the battery compartment.Excessive sealant and cracks were identified on the motor mount which appears to be allowing fluid to leak through the motor; corrosion was also noted.Based on the investigation and sample evaluation, the root cause was assessed to be manufacturing related.Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
As reported per maude event report (mw5096517): "the x-stream tubing set w/ nd trumpet valve was checked by biomed on 04-sep-2020 and found no issues." addendum per additional information: it was reported, during set up of a procedure, during the priming of the x-stream tubing set, it was noted that there was leaking of the saline irrigation fluid from the bottom of the cassette/housing chamber.The or staff removed the tubing set, used another set in the same controller without any issues.There was no patient involvement.

• 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: 10759143
• Report Number: 1213643-2020-20025
• Device Sequence Number: 11562052
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: JUET3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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