MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv1332 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch that "an 18g 4f power picc solo catheter having difficulty with flushing picc line removed with difficulty.Resistance noted and requiring muscle massage.Distal 5cm of line noted to be tortuous upon removal." no other information was provided.

• Brand Name: POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8296948
• Report Number: 3006260740-2019-00149
• Device Sequence Number: 2141602
• Product Code: LJS
• UDI-Device Identifier: 00801741027727
• UDI-Public: (01)00801741027727
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2019
• Report Date (Section F): 12/11/2018

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 3194108D
• Device Lot Number: RECV1332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/11/2018