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 Break (1069)

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

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the during the procedure, the physician found "catheter tip broken".A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen 7frx20cm cvc for analysis, which does not match the reported catheter - product code cs-27702-e (2-lumen 7frx20cm).The customer was contacted as part of this discrepancy; however, no information was provided.Signs of use in the form of biological material was observed inside the extension lines.Additionally, the catheter body was intentionally severed.The severed end was not returned.Visual analysis revealed that the proximal extension line was separated directly adjacent to the proximal hub (white hub).Microscopic examination confirmed the damage and revealed that the edges of the separation were smooth and uniform.Additionally , remanence of the extension line were still inside the proximal hub.A manual tug test confirmed that the distal and medial extension lines were secure within the respective hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs 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.".The report of a separated extension line was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the proximal extension line had separated directly adjacent to the luer hub (white hub).Despite this, dimensional and functional analysis could not be performed as the correct material number for the returned catheter is not known.A device history record review was performed based on a potential lot for the reported material number, and no relevant findings were identified.Based on the discrepancy between the reported part number and the returned device, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the during the procedure, the physician found "catheter tip broken".A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.

• 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: 16445474
• MDR Text Key: 310286671
• Report Number: 3006425876-2023-00207
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-27702-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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