MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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 redv2044 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redv2044) have been reported from the same facility.
Event or Problem Description
It was reported: "8/21 @ 1430, vascular access team called to assess gray lumen.Noted subtle kink in line.Removed dressing, straightened out the line; catheter flushed easily, with brisk blood return; new dressing placed." "placement info: 5 fr triple lumen provena powerpicc placed in the right upper arm, brachial vein.12 cm external length; securacath in place".No pt harm reported.

• Brand Name: POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-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: 10583487
• Report Number: 3006260740-2020-03357
• Device Sequence Number: 16801305
• Product Code: LJS
• UDI-Device Identifier: 00801741028168
• UDI-Public: (01)00801741028168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3385108Q
• Device Lot Number: REDV2044
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 104