MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 10F TL CV CATHW/ SURECUFF TISSUE INGROWTH CUFF (W/ PEEL-APART INTR); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	0606564
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
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.Device not yet returned.
Event or Problem Description
It was reported by the sales rep that the facility had a device that during the flushing protocol, after receiving cryotherapy , the catheter was flushed with a 10 ml syringe and the white port popped on the nurse.The catheter was then exchanged with a different lot # and the procedure was completed without a problem.

• Brand Name: HICKMAN 10F TL CV CATHW/ SURECUFF TISSUE INGROWTH CUFF (W/ PEEL-APART INTR)
• 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: 6788658
• Report Number: 3006260740-2017-01296
• Device Sequence Number: 1339099
• Product Code: LJS
• UDI-Device Identifier: 00801741052026
• UDI-Public: (01)00801741052026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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: 0606564
• Device Catalogue Number: 0606564
• 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: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1