MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR TL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9396108D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, as the device was discarded after the event occurred.A lot history review (lhr) of reay0582 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that they are experiencing difficulty inserting and withdrawing the guidewire.Once the guidewire is inserted through the needle guide the wire ¿gets stuck¿ and the healthcare professional (hcp) is unable to withdraw unless the guidewire and the needle are removed together.After the device was removed the hcp was still not able to withdraw the guidewire from the needle, as if there was a ¿knot in the wire¿.Hcp used a micro-ez and guidewire to complete the procedure.No patient injury was reported.

• Brand Name: 6 FR TL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT
• 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: 6568027
• Report Number: 3006260740-2017-00616
• Device Sequence Number: 16345902
• Product Code: LJS
• UDI-Device Identifier: 00801741035937
• UDI-Public: (01)00801741035937(17)180430(10)REAY0582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K0702230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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: 04/30/2018
• Device Catalogue Number: 9396108D
• Device Lot Number: REAY0582
• 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: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1