MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Gas/Air Leak (2946)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that syringe leakage.The issue was identified during use on patient.There was no reported patient harm or consequence.Additional information has been requested from the account.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The customer provided one photo for analysis.The customer returned one introducer needle for analysis.Signs of use were observed inside the needle hub.Visual analysis of the returned needle revealed one large vertical crack in the needle hub.It was confirmed that the hub on the returned sample was the new hub design, which matched the bill of materials.The needle length measured 68" via calibrated ruler, which was within the specifications of 67.49mm-69.27mm per needle product drawing.The needle cannula outer diameter (od) measured 0.04988" via calibrated micrometer which was within the specifications of 0.0495"-0.0505" per the cannula product drawing.The needle cannula inner diameter (id) measured 0.041" via calibrated pin gauge, which was within the specifications of 0.041"-0.043" per the cannula product drawing.Functional testing was performed per the product ifu, which states "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the returned introducer needle was attached to a lab inventory arrow raulerson syringe (ars).The returned needle was not able to draw or aspirate water due to the cracks in the needle hub.A device history record review was performed, and no relevant findings were identified.Based on these circumstances and the comments from r & d, the root cause of this complaint was design related.Teleflex has identified that the needle hub material was 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.Capa has been initiated under teleflex's quality system by the manufacturing site to further address this complaint issue.Corrective actions have not been implemented at the time of the report.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "syringe leakage." the issue was identified during use on patient.There was no reported patient harm or consequence.Additional information has been requested from the account.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17198357
• MDR Text Key: 318237806
• Report Number: 9680794-2023-00450
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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 Expiration Date: 04/06/2024
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22E1138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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.