MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 3295335

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, frequency 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 bleed back was inconclusive due to the sample condition and because clinical conditions could not be replicated.One 5fr d/l powerpicc solo was returned for investigation.The extension leg had been cut 4mm from the distal end of the purple solo connector.The d/l tubing extended 43.1cm from the distal end of the bifurcation.The solo valve was in its proper position.A functional test revealed that catheter was patent to infusion.A microscopic examination revealed residue from use on the solo valve.One of the benefits of the proximal (solo) valve is to reduce blood reflux compared to open-ended catheters.While the exact cause of the reported event was unknown, the product ifu provides instructions for flushing and maintaining the catheter to keep the valve clean.The syringe should be removed slowly while injecting the last 0.5ml of saline.This helps prevent a vacuum which can pull a small amount of blood into the tip of the catheter.Injection caps or end caps should be attached to the catheter hub and securely tightened.Injection caps should be changed every seven days or per agency policy, when the injection cap has been removed for any reason, or anytime the cap appears damaged, is leaking, or blood is seen in the catheter without explanation or blood residue is observed in the injection cap.A lot history review (lhr) of rebv0019 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there was continuous bleed back from the purple lumen after placement.They performed an over-the-wire replacement and inserted a new catheter.No patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7522378
• MDR Text Key: 108751239
• Report Number: 3006260740-2018-00986
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3295335
• Device Catalogue Number: 3295335
• Device Lot Number: REBV0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1