MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problem Crack (1135)

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

Event Date 07/30/2021

Event Type  malfunction  

Event Description

It was reported the extension line was found cracked during patient use.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 2 lumen catheter for investigation.Visual inspection of the catheter revealed signs of use in the form of biological material.No other defect or anomalies were identified.The catheter length from the juncture hub to the distal end measured 214mm, which is within the specification limits of 207mm-227mm per the catheter graphic.The catheter outer diameter measured 3.993mm, which is within the specification limits of 3.96mm-4.06mm per the catheter extrusion graphic.The catheter was leak tested by injecting water into each extension line using a 5ml syringe.The distal end of the catheter was occluded during testing to restrict flow.No leaks or air bubbles were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not clamp the body of the large-bore catheter.Clamp only the extension lines and use only the clamps provided.Never use serrated forceps to clamp the extension lines." the reported complaint of extension line cracked could not be confirmed by the complaint investigation.The sample passed dimensional and functional testing.No cracks, tears or leaks were found.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.No problem was found with the returned sample.Teleflex will continue to monitor and trend for results of this complaint issue.

Event Description

It was reported the extension line was found cracked during patient use.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• 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: 12992442
• MDR Text Key: 282284876
• Report Number: 3006425876-2021-01146
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F20H2873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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.