MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN915773

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

It was reported "during the insertion of a cvc, it was noted that the needle was defective.Air was aspirated even the position of the needle was safe in the vessel.Shortly thereafter, the needle broke.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4) the actual device was not returned; however, the customer provided three photos for analysis.The complaint of needle hub broke and separated was able to be confirmed by the photos.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "during the insertion of a cvc, it was noted that the needle was defective.Air was aspirated even the position of the needle was safe in the vessel.Shortly thereafter, the needle broke.".

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 14495275
• MDR Text Key: 292584728
• Report Number: 3006425876-2022-00484
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/27/2023
• Device Model Number: IPN915773
• Device Catalogue Number: UF-24854
• Device Lot Number: 71F21H0273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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