MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS; INTRODUCER, CATHETER

Catalog Number CDC-45563-VPS2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The nurse reports that the picc was placed on (b)(6) 2020 and confirmed with vps bbe.On subsequent chest x-ray, radiology determined tip position was 4 cm deep.Catheter was pulled back and then repeat x-ray showed catheter tip at caj.

Manufacturer Narrative

Qn# (b)(4).It was reported "picc was placed on 5/8/20 and confirmed with vps bbe.On subsequent chest x-ray, radiology determined tip position was 4 cm deep".No sample or case data were returned for review.A device history record review was performed and did not reveal any manufacturing related issues.A probable cause of this issue could not be determined based on the information provided and without a sample.No further action will be taken.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The nurse reports that the picc was placed on 5/8/20 and confirmed with vps bbe.On subsequent chest x-ray, radiology determined tip position was 4 cm deep.Catheter was pulled back and then repeat x-ray showed catheter tip at caj.

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10086706
• MDR Text Key: 192016032
• Report Number: 1036844-2020-00160
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CDC-45563-VPS2
• Device Lot Number: 23F19G0114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1