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 Problems Material Separation (1562); Fitting Problem (2183)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the luer hub connection was found not secure" during patient use.No patient harm was reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the luer hub connection was found not secure" during patient use.No patient harm was reported.

Event Description

It was reported "the luer hub connection was found not secure" during patient use.No patient harm was reported.

Manufacturer Narrative

(b)(4).The customer returned one 2-l cvc and stopcock for analysis.The proximal luer hub was not returned.Visual inspection revealed the proximal luer hub was separated from its extension line.The point of separation is unknown as the proximal luer hub was not returned.The separation point on the extension line was rough and jagged.The catheter body measured 216mm which is within the specification limits of 207-227mm per catheter product drawing.The proximal extension line outer diameter measured 2.396 which is within the specification limits of 2.39-2.49mm per proximal extension line extrusion graphic.The proximal extension line inner diameter measured 1.651 mm, which is within the specification of 1.65-1.75mm per proximal extension line extrusion graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal extension line was flushed using a 5cc syringe, and it flushed as expected.A manual tug test confirmed the distal extension line was secure to the luer hub.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "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 extension line separated from its luer hub; however, the separated luer hub was not returned for evaluation.The probable root cause of this event could not be determined without the separated luer hub returned for analysis.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: 14518522
• MDR Text Key: 292809765
• Report Number: 3006425876-2022-00493
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/29/2023
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F21D2776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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; NOT REPORTED