MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX8CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-00820-FLH

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the endurance was placed with no issue.After a few uses, it was noted that the line was leaking near the first line from the hub.Fracture noted.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was not delayed/interrupted.

Manufacturer Narrative

Qn#(b)(4).The customer returned one endurance catheter assembly and lidstock for evaluation.The device contained significant signs of use in the form of biological material.After the sample failed functional testing, the catheter body was microscopically examined.A small slit was found in the catheter near the juncture hub.The slit was smooth and blunt, which is damage consistent with the catheter coming in contact with a sharp object (i.E.Needle bevel).The catheter body contained a small slit 80 mm from the distal tip.The total length of the catheter body measured to be 85 mm which is consistent with the nominal value of 85 mm per product drawing.The outer diameter of the catheter body measured to be 0.041" which is within specifications of 0.038-0.048" per product drawing.The catheter was initially flushed to ensure no blockages were present.The distal tip was then clamped and the catheter was pressurized using a lab inventory syringe.A small leak was detected in the catheter body near the juncture hub.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "prior to insertion, distal tip of catheter must be fully retracted past needle bevel or catheter tip damage may occur".The customer report of an endurance leak was confirmed by complaint investigation of the returned sample.The endurance catheter body contained one slit near the juncture hub.The damage was consistent with sharps causing the leak.The sample passed all relevant dimensional testing and a device history record review was performed with no relevant findings.Based on the sample received, unintentional user error (contact with sharps) caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the endurance was placed with no issue.After a few uses, it was noted that the line was leaking near the first line from the hub.Fracture noted.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was not delayed/interrupted.

• Brand Name: ARROW EXT DWELL CATH BASIC 20GAX8CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9595635
• MDR Text Key: 177596201
• Report Number: 9680794-2020-00023
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K163513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: ASK-00820-FLH
• Device Lot Number: 13F19K0281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1