MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-24301-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was found leaking during patient use.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one opened cvc with multiple components, including a spring wire guide and an introducer needle, for evaluation.The catheter was not returned.Visual and functional inspection of the catheter could not be performed as it was not returned for analysis.A device history record review was performed, and no relevant findings were identified.The customer report of a catheter leak in use could not be confirmed by complaint investigation of the returned sample.The customer did not return the catheter, therefore no visual, dimensional, or functional analysis could be performed.The root cause for this complaint could not be determined without the complete sample returned for analysis.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the catheter was found leaking during patient use.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13764412
• MDR Text Key: 287248966
• Report Number: 3006425876-2022-00216
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/08/2023
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F21D1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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