MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI; CATHETER INTRAVASCULAR THERAPE

Catalog Number PR-35052-HPHNM

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported during ct abdomen with contrast, the picc lumen was accessed appropriately (pink lumen aspirating and flushing prior to connection of contrast), however when radiographer attempted to start contrast injection at 2.5ml/sec, injector indicating high pressure.Scan stopped and picc inspected.Pt stated he heard a noise from his picc and then felt moisture on his pillow.On inspection of the picc, a split was noted on the white catheter below the level of the hub.The picc was secured and the picc was removed on the ward.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported during ct abdomen with contrast, the picc lumen was accessed appropriately (pink lumen aspirating and flushing prior to connection of contrast), however when radiographer attempted to start contrast injection at 2.5ml/sec, injector indicating high pressure.Scan stopped and picc inspected.Pt stated he heard a noise from his picc and then felt moisture on his pillow.On inspection of the picc, a split was noted on the white catheter below the level of the hub.The picc was secured and the picc was removed on the ward.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and one relevant finding was identified.A non-conformance was initiated for lot 13p21f0249 in regard to resin not according to specification.Without the sample returned, it cannot be determined if the failure mode of this complaint is the same as the non-conformance 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.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15156800
• MDR Text Key: 302479245
• Report Number: 9680794-2022-00470
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 13F21H0484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.