MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-45703-XP1A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported medication was leaking at the "connection site where the medication port line meets the piece that goes into the patient".The device was placed several days before the issue occurred.No patient harm was reported.No medical intervention was required.The patient's condition is reported as fine.

Event Description

It was reported medication was leaking at the "connection site where the medication port line meets the piece that goes into the patient".The device was placed several days before the issue occurred.No patient harm was reported.No medical intervention was required.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter and extension lines revealed no obvious defects or anomalies.The catheter body length measured 214mm, which is within the specifications of 207-227mm per product drawing.The distal extension line outer diameter measured 0.08653", which is within the specifications of 0.084-0.088" per product drawing.The distal extension line inner diameter measured 0.058", which is within the specifications of 0.055-0.059" per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection was performed on the returned catheter to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all extension lines flushed as expected.The extension lines were tested for liquid leakage per amrq-000071 rev.12 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the catheter body or extension lines.A manual tug test confirmed the extension lines were fully secured within their respective hubs.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of an extension line leak could not be confirmed by complaint investigation of the returned sample.The returned catheter showed no visual defects or anomalies, and no leaks were observed during functional testing performed according to bs en iso 10555-1 annex c.The catheter passed all relevant dimensional inspection.Based on the customer report and the sample returned, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• 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: 15974575
• MDR Text Key: 306157702
• Report Number: 9680794-2022-00782
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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.