MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7711700
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2016
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 rezi0047 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - facility reported to the sales representative that during the tunneling procedure and adjustment of the catheter placement, the dacron cuff came dislodged from the catheter.This necessitated the removal of the item and replacement with the second catheter.No patient harm reported.

• Brand Name: GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6056074
• Report Number: 3006260740-2016-00561
• Device Sequence Number: 911927
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736(17)20080828(10)REZI0047
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

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: 08/28/2020
• Device Catalogue Number: 7711700
• Device Lot Number: REZI0047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1