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 07/20/2021

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).

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).The customer returned one 3-l cvc catheter for analysis.Signs of use in the form of biological material was observed on the extension lines.The separated portion of the distal extension line was not returned.Visual inspection confirmed the distal luer hub separated from the distal extension line.The separation point was rough and jagged.The customer report of an extension line separation could be confirmed through visual inspection of the returned sample.The distal luer hub separated from its extension line.However, without the luer hub returned for analysis, the point of separation could not be determined.Based on the customer report, the incorrect material number, and the missing luer hub, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 12992598
• MDR Text Key: 282284503
• Report Number: 3006425876-2021-01147
• 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
• 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: 03/18/2022
• Supplement Dates FDA Received: 03/20/2022
• 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