MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR TL POWERPICC SOLO NURSE FULL WITH MI; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	3396108
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 for evaluation.A lot history review (lhr) of rebq0918 showed five other similar product complaint(s) from this lot number.The complaints for this lot number (rebq0918) have been reported from the same facility.
Event or Problem Description
It was reported by the facility that they have had six picc's break where the connector is, they stated it appeared to be cracking.No patient injury was reported.This file addresses patient six.On (b)(6) 2017 - facility reported use of chlorehexadine and places swabcaps on the picc lumens.

• Brand Name: 6 FR TL POWERPICC SOLO NURSE FULL WITH MI
• 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: 6685940
• Report Number: 3006260740-2017-00977
• Device Sequence Number: 45704
• Product Code: LJS
• UDI-Device Identifier: 00801741028397
• UDI-Public: (01)00801741028397
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2017

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: 08/31/2018
• Device Model Number: 3396108
• Device Catalogue Number: 3396108
• Device Lot Number: REBQ0918
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1