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

Catalog Number	5552002
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Based on not having the sample returned to evaluate, no conclusion can be made.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.Should additional information be provided and/or the sample is returned a supplemental emdr will be submitted.
Event or Problem Description
It was reported that during a warehouse inspection at the hospital, a hair-like foreign material was observed inside the x-stream tubing set w/nd trumpet valve packages.There was no patient involvement as the reported product issue was discovered during inspection.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10372359
• Report Number: 1213643-2020-07150
• Device Sequence Number: 3001674
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: Other
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 5552002
• Device Lot Number: JUDRF148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1