MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recu0701 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported by the nurse that "2-lumen catheter was infused with parenteral nutrition in the red lumen, but parenteral nutrition returned through the purple lumen, which did not allow the use of the purple route.Even with a gravitational infusion, the parenteral nutrition returned.Parenteral nutrition was being infused in an infusion pump.A x-ray was performed and confirmed the catheter tip in central access by the intensive care physician.It was stated there is a communication of the lumens.

Event Description

It was reported by the nurse that "2-lumen catheter was infused with parenteral nutrition in the red lumen, but parenteral nutrition returned through the purple lumen, which did not allow the use of the purple route.Even with a gravitational infusion, the parenteral nutrition returned.Parenteral nutrition was being infused in an infusion pump.A x-ray was performed and confirmed the catheter tip in central access by the intensive care physician.It was stated there is a communication of the lumens.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of lumen communication is unconfirmed as the problem was not found on the returned sample.One 5 fr dl powerpicc catheter was returned for investigation.Use residue was observed throughout the sample.Injection caps were returned attached to both luer hubs.The extension tubing was returned clamped.Both catheter lumens were flushed with water using a 12 ml syringe and were found to be patent to infusion.The infusion caps were removed.The distal end of the catheter was clamped and each lumen was individually pressurized and aspirated.No water was observed to leak through to the connecting lumen.Since no issues were observed during functional testing of the returned sample, the complaint is unconfirmed.A lot history review (lhr) of recu0701 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• 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
• MDR Report Key: 8500408
• MDR Text Key: 141929063
• Report Number: 3006260740-2019-00833
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918
• Combination Product (y/n): N
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3275118
• Device Lot Number: RECU0701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR