MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4 FR SINGLE LUMEN W/TLS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
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 redp3221 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2019, nurse assessed that there was fair blood returns and queried leaking saline and some blood at site when pt was in for picc care and blood work at oncology.Picc nurse assessed same day and found no leak at that time.On (b)(6) 2019 pt received chemo tx paclitaxel and carboplatin, and picc nurse was notified the following week that the tx room nurse found leaking from insertion site with no blood returns again.Picc nurse confirmed leaking at the site.Picc was withdrawn 2 cm.Flushed and still had leaking.A picc exchange was attempted and unsuccessful due to line curling in the axilla.Line was removed.New line insertion in new site on same date ((b)(6) 2019).On review of the original line, an hole was found at the 20 cm mark.

• Brand Name: POWERPICC SOLO 4 FR SINGLE LUMEN W/TLS
• 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: 9856807
• Report Number: 3006260740-2020-00906
• Device Sequence Number: 2611518
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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 Model Number: N/A
• Device Catalogue Number: 9194118
• Device Lot Number: REDP3221
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1