MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SA-25703-EU

Device Problem Crack (1135)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that "doctor noticed a crack in the hub of the introducer needle prior to using.He noticed air leaking through hub." this was found prior to use on the patient during functional testing.No patient harm or injury.A new set was used to complete the procedure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one video showing an introducer needle hub being flushed with a syringe.Fluid is visibly leaking from a crack on the needle hub.Therefore, the reported defect is confirmed.A device history record review was performed, and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through visual inspection of the customer supplied video.The failure mode identified is consistent with the failure mode investigated under a previously opened capa.Based on the capa investigation, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol based disinfectants.A capa was fully implemented 23-aug-2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "doctor noticed a crack in the hub of the introducer needle prior to using.He noticed air leaking through hub." this was found prior to use on the patient during functional testing.No patient harm or injury.A new set was used to complete the procedure.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• 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: 19013601
• MDR Text Key: 339062582
• Report Number: 3006425876-2024-00311
• 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,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SA-25703-EU
• Device Lot Number: 71F23D0666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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: NONE REPORTED; NONE REPORTED