MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 2-L 16 GA X 19-1/2" (50 CM); CATHETER INTRAVASCULAR THERAPE

Catalog Number PS-01652

Device Problems Obstruction of Flow (2423); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Dhr conducted and no relevant findings were noted.

Event Description

The customer reports that the catheter is occluded and there is a return of liquid by the alternate road (line).Another device was used.

Manufacturer Narrative

(b)(4).The customer returned one, two-lumen picc for analysis.Signs-of-use in the form of biological material was observed in the proximal skive hole.After failing functional and additional testing, the catheter juncture hub was cross sectioned.Microscopic examination of the cross section revealed a small hole between the proximal and distal lumens.This is the likely cause of the backflow.The distal end of the catheter body was occluded.When the proximal lumen was pressurized, backflow was observed from the distal extension line.When the distal lumen was pressurized, backflow was observed from the proximal lumen.Water was injected through both lumens without occluding the catheter body.Both lumens functioned as intended with no observed backflow.The catheter body was occluded directly below the juncture hub.Backflow was observed coming from both extension lines when pressurizing the respective lumen.This indicates that the defect lies within the juncture hub.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The report of inter-lumen cross over was confirmed through complaint investigation.Functional testing confirmed that there was backflow coming from both the proximal and distal extension lines when pressurizing the alternate lumen.Visual analysis revealed a hole between the proximal and distal lumens, which was the likely cause of the backflow.Based on the customer description and the sample received, manufacturing caused or contributed to this event.A non-conformance request to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the catheter is occluded and there is a return of liquid by the alternate road (line).Another device was used.

• Brand Name: ARROW PICC SET: 2-L 16 GA X 19-1/2" (50 CM)
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9340595
• MDR Text Key: 177773310
• Report Number: 9680794-2019-00451
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/03/2021
• Device Catalogue Number: PS-01652
• Device Lot Number: 14F19D0332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1