MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number SA-22855-EU

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reported a cracked needle hub.No patient harm was reported.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with one relevant finding.A non-conformance was initiated for material k-04300-019c, lots 14p21c0042 and 14p21c0244 for potential issues with drying during supplier manufacturing.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

Customer complaint reported a cracked needle hub.No patient harm was reported.

• Brand Name: ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 13839982
• MDR Text Key: 287544253
• Report Number: 3006425876-2022-00240
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: SA-22855-EU
• Device Lot Number: 71F21F1591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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
• Patient Age: 79 YR