MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 20GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00620

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the line was placed on 14-may in the left upper arm brachial vein.The rn was doing a routine dressing change and noticed a fractured line.It was reported the patient was asymptomatic and was sent to interventional radiology to get the internal catheter removed.The patient's condition was reported to be fine.It was reported the patient had a history of pulling out his lines and customer suspected this is what happened.

Event Description

It was reported the line was placed on 14-may in the left upper arm brachial vein.The rn was doing a routine dressing change and noticed a fractured line.It was reported the patient was asymptomatic and was sent to interventional radiology to get the internal catheter removed.The patient's condition was reported to be fine.It was reported the patient had a history of pulling out his lines and customer suspected this is what happened.

Manufacturer Narrative

(b)(4).The customer provided three images showing a defective endurance catheter assembly.Visual analysis revealed that the catheter body was separated towards the juncture hub.The customer also returned one endurance catheter assembly for analysis.Signs of use in the form of biological material were observed inside the catheter body.Visual analysis of the returned sample revealed that the catheter body was separated towards the juncture hub.Microscopic examination confirmed the damage and revealed that the point of separation was smooth, uniform and oval shaped.This damage is consistent with the catheter becoming kinked at the insertion site, which weakens the catheter body.The point of separation measured 4mm from the juncture hub.The catheter body total length from the juncture hub to the distal tip measured 65mm, which equals the nominal value of 65mm per the catheter assembly product drawing.The catheter body outer diameter measured.0420", which is within the specification limits of.0410"-.0450" per the catheter body extrusion product drawing.The catheter body inner diameter at the point of separation measured.031", which is within the specification limits o f.030"-.034" per the catheter body extrusion product drawing.Functional inspection was performed per the product ifu states, "engage extension line clamp and remove the vent plug from catheter extension line luer hub, attach a 10 ml syringe filled with normal sa line for injection, unclamp and check for brisk free-flowing blood return, flush, and reengage extension line clamp".The endurance catheter was connected to a lab inventory water-filled syringe.When the catheter was flushed, water passed through the catheter body and exited out of the point of separation.The manufacturing facility has been previously contacted as part of this complaint investigation.It was stated that in-process inspection includes 100% leak testing of molded pieces to verify catheter structural integrity.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit cautions the user "do not raise the catheter beyond 90 relative to the skin to avoid catheter kinking and damage." the ifu also states "do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations".The report of a cut endurance catheter was confirmed through complaint investigation.Visual and microscopic examination revealed that the catheter body was separated adjacent to the juncture hub.The point of separation appeared smooth and oval shaped.The damage observed was consistent with the device being kinked at the insertion site, which caused a weakening in the material extrusion.Despite the damage, the catheter met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Manufacturing engineering were consulted who stated that this product undergoes in-process inspection which includes 100% leak testing of molded pieces prior to release.Based on the customer report that the defect was observed during use and the appearance of the damage on the returned device, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14680944
• MDR Text Key: 294058841
• Report Number: 9680794-2022-00367
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F22C0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention
• Patient Sex: Male