MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; 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	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recw0104 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was leaking from the red lumen at the bifurcation.On (b)(6) 2019- additional information received from facility stated, "upon completion of insertion we noticed damaged whereas leaking was noticed.Damaged picc was replaced and have to start a new procedure".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was inconclusive due to the nature of the returned evidence.The product returned for evaluation was one photograph depicting a 5fr d/l powerpicc solo catheter.The depicted sample was placed in a re-sealable bag.A red circle had been inscribed on the photograph around the red-luered extension tubing near the molded joint.No obvious damage or evidence of leakage was observed during inspection of the provided photograph.Inspection of the provided photograph was insufficient to evaluate possible damage/leakage.Consequently this complaint is inconclusive at this time.
Event or Problem Description
It was reported that the catheter was leaking from the red lumen at the bifurcation.(b)(6) 2019- additional information received from facility stated, "upon completion of insertion we noticed damaged whereas leaking was noticed.Damaged picc was replaced and have to start a new procedure.".

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: 8724340
• Report Number: 3006260740-2019-01744
• Device Sequence Number: 2021969
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: (01)00801741154904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD2
• Device Lot Number: RECW0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1