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 Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician found foreign material inside the arrow raulerson syringe when the physician withdrew the spring wire guide from the syringe.The issue was detected prior to patient use.No patient involvement with the device was reported.

Manufacturer Narrative

Qn#: (b)(4).The customer provided five photos and one video for analysis.The photos and video confirm that there were foreign particulates coming from inside the arrow raulerson syringe (ars) valve.The customer also returned an opened cvc kit including an introducer needle , guide wire assembly, and an ars for evaluation.Visual inspection revealed that there were no signs of use observed.Foreign material was observed on the guide wire assembly and within the ars handle.Microscopic examination confirmed the foreign material inside the ars handle and on the guide wire assembly.The sample was sent for ftir testing of the foreign material.The material matches those of poly-isoprene or styrene isoprene.R & d stated that the only component in the finished good kit would be the wire snubber (k-04210-003a) found on the swg assembly.The material used is styrene copolymer which matched with the ftir report.In addition , "wire snubbers are received in bulk non-sterile in polybags.So it is possible that some small particles made into the kit." a device history record review was performed, and no relevant findings were identified.The complaint of foreign material inside device was confirmed through investigation of the returned sample.Visual analysis revealed foreign material was observed on the guide wire assembly and within the ars handle.Ftir analysis performed revealed that the material profile is consistent with the wire snubber component.Based on wire snubber being a purchased component, the root cause was determined to be supplier related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported the physician found foreign material inside the arrow raulerson syringe when the physician withdrew the spring wire guide from the syringe.The issue was detected prior to patient use.No patient involvement with the device was reported.

• 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 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: 17481563
• MDR Text Key: 320613251
• Report Number: 3006425876-2023-00754
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• 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: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22H1871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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: N/A.; N/A.