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	01/09/2019
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 recw1720 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the extension leg tubing turn black on both lumens.It was stated the only medications that were infused were ceftriaxone 2g qhs and ns.
Event or Problem Description
It was reported that the extension leg tubing turn black on both lumens.It was stated the only medications that were infused were ceftriaxone 2g qhs and ns.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of catheter discoloration was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc solo catheter.Usage residues were observed throughout the sample.Both extension tubes appeared discolored.Following longitudinal bisection of one tube within the discolored region, inspection of the inside surface revealed the discoloration to be more extensive.Microscopic inspection sample confirmed that the material of the extension tubes was discolored.The inside surface was scraped using an instrument confirmed that the discoloration permeated the extension tubing material.The observed material discoloration appeared to be more severe on the inside, suggesting that an infusate or combination of infusates may have contributed; however, the source of the discoloration could not be identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of recw1720 showed no other similar product complaint(s) from this lot number.

• 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: 8323206
• Report Number: 3006260740-2019-00201
• Device Sequence Number: 16181573
• Product Code: LJS
• UDI-Device Identifier: 00801741155017
• UDI-Public: (01)00801741155017
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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 Model Number: N/A
• Device Catalogue Number: S1295108FD3
• Device Lot Number: RECW1720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1