MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM GUIDEWIR; LONG TERM INTRAVASCULAR CATHETER

Model Number	3295355F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2017
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) of rebs1627 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that during placement the guidewire was inserted into the introducer and the guidewire would not go past the needle.Guidewire was removed and the end appeared to be "mangled".Opened another kit the facility had in stock and used the guidewire from that kit to complete the procedure.No harm to the patient.

• Brand Name: POWERPICC SOLO FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM GUIDEWIR
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6945121
• Report Number: 3006260740-2017-01828
• Device Sequence Number: 13623967
• Product Code: LJS
• UDI-Device Identifier: 00801741028151
• UDI-Public: (01)00801741028151
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 3295355F
• Device Catalogue Number: 3295355F
• Device Lot Number: REBS1627
• 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: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1