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).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

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: 9340554
• MDR Text Key: 177774139
• Report Number: 9680794-2019-00449
• 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?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1