MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Material Separation (1562)

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

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "the luer-hub (white head) had falling off from catheter." no patient harm reported.The catheter was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

Qn #(b)(4).The customer returned the proximal luer hub of a 3 lumen cvc and the swg for analysis.The proximal extension line was not returned for analysis.The proximal luer hub will be analyzed as part of this investigation.Visual analysis revealed that the proximal luer hub (white hub) had separated from the assembly; however, the proximal extension line was not returned for analysis.Remains of the extension line were found inside the luer hub.The customer did not return the rest of the catheter.The inner diameter of the proximal lumen measured to be 1.4732 mm which is within specifications of 1.42-1.50 mm per product drawing.The returned catheter luer hub was not able to be functionally tested due to the damage and the lack of the entire catheter returned for analysis.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of an extension line/luer hub separation was confirmed by complaint investigation of the returned sample.The proximal luer was separated and contained remnants of the extrusion within the hub.However, the proximal extension line was not returned for analysis.The sample passed all relevant dimensional inspections, and a device history record review was performed with no relevant findings.Based on the sample received, a root cause could not be determined without the rest of the catheter returned for analysis.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

The complaint is reported as: "the luer-hub (white head) had falling off from catheter." no patient harm reported.The catheter was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12832553
• MDR Text Key: 280947481
• Report Number: 3006425876-2021-01075
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21A2046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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
• Treatment: NOT REPORTED; NOT REPORTED