MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 9.5 FR DUAL LUMEN GROSHONG 18CM TIP TO CUFF WITH PEEL APART INTRODUCER WILL CONV; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	6626954
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
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, at this time, for evaluation.A lot history review (lhr) of reay0111 showed no other similar product complaint(s) from this lot number.Device, not yet returned.
Event or Problem Description
It was reported that the catheter plastic softened in situ which caused it to dislodge.No patient injury was reported.

• Brand Name: 9.5 FR DUAL LUMEN GROSHONG 18CM TIP TO CUFF WITH PEEL APART INTRODUCER WILL CONV
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6900557
• Report Number: 3006260740-2017-01719
• Device Sequence Number: 1111207
• Product Code: LJS
• UDI-Device Identifier: 00801741041563
• UDI-Public: (01)00801741041563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/28/2017
• Report Date (Section F): 08/11/2017

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: 6626954
• Device Catalogue Number: 6626954
• Device Lot Number: REAY0111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/11/2017