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

Catalog Number	5552003
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the subject product found a hair like foreign matter caught in the package seal resulting in partial exposure of the material on both side of the tyvek lid seal.When the package was opened and the foreign matter was removed, a impression in the seal residual was visible in the lid seal where the foreign matter was located, which could result in compromised sterility.A three year review of complaint history for the product family found this to be the first complaint reported for the subject lot of (b)(4) units manufactured in february of 2017 and the first complaint of foreign matter found in the packaging seal area.This occurrence is being reviewed with the manufacturing facility.The information provided by bard 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 bard.
Event or Problem Description
Information as reported by the customer contact: a package of davol x-stream tubing was brought to me with a hair sterilized in the package.The hair is actually caught in the seal of the package, so it is both inside and outside of the package.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM
• 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: 6600867
• Report Number: 1213643-2017-00329
• Device Sequence Number: 767716
• Product Code: GCJ
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101(17)200128(10)JUBPF258
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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: 01/28/2020
• Device Catalogue Number: 5552003
• Device Lot Number: JUBPF258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1