MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the patient, via (b)(4) that she had to have her groshong catheter replaced on (b)(6) 2017.She stated that she had the exact same type of catheter placed after removal of the damaged one, but the surgeon had to insert it through a new site.The patient requested a new id card, which (b)(4) sent to her.No other information was provide.No harm to the patient was reported.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER WITH SURECUFF
• 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: 6624732
• Report Number: 3006260740-2017-00752
• Device Sequence Number: 613933
• Product Code: LJS
• UDI-Device Identifier: 00801741041587
• UDI-Public: (01)00801741041587
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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 Model Number: N/A
• Device Catalogue Number: 7726954
• 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: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1