MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 9.5 FR DUAL LUMEN CATHETER, 5 CM CUFF LOCATION, INTERMEDIATE KIT; LONG TERM INTRAVASCULAR CATHETER

Model Number	0805910
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebr0678 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
Per sales rep, the facility reported that upon opening the package, one half of the valve assembly was found broken within the kit.A second device/package was opened to complete the procedure.

• Brand Name: 9.5 FR DUAL LUMEN CATHETER, 5 CM CUFF LOCATION, INTERMEDIATE KIT
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6765752
• Report Number: 3006260740-2017-01220
• Device Sequence Number: 882153
• Product Code: LJS
• UDI-Device Identifier: 00801741036682
• UDI-Public: (01)00801741036682
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 03/31/2019
• Device Model Number: 0805910
• Device Catalogue Number: 0805910
• Device Lot Number: REBR0678
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1