MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT ETOH PPICC SOLO MAX, 5F TL FULL W 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	1395108DE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the healthcare professional pulled the guidewire through the membrane and the guidewire fractured at the 28m, from the end of the guidewire.No other information has been provided, but requested.No patient injury was reported.

• Brand Name: DOT ETOH PPICC SOLO MAX, 5F TL FULL W 3CG
• 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: 6499034
• Report Number: 3006260740-2017-00423
• Device Sequence Number: 797226
• Product Code: LJS
• UDI-Device Identifier: 00801741128400
• UDI-Public: (01)00801741128400(10)REAT2004
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2017

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 Catalogue Number: 1395108DE
• Device Lot Number: REAT2004
• 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: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1