MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM TUBING SETS; LAPAROSCOPIC, 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)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection demonstrates a hair inside of the sealed product packaging.The foreign material does not extend beyond the seal which remains intact.Based on the investigation performed and sample evaluation, the foreign hair presented during the manufacturing process prior to the packaging being sealed.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2020.Awareness training was provided to the appropriate associates.
Event or Problem Description
As reported, there was a hair partially inside the unopened package of an x-stream tubing set w/ nd trumpet valve.It is alleged that the unopened packaging was contaminated.The device was not used on the patient.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10264852
• Report Number: 1213643-2020-06579
• Device Sequence Number: 3004606
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: 01/28/2023
• Device Catalogue Number: 5552002
• Device Lot Number: JUEN2741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1