MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed , and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed , and the probable cause could not be determined from the available information.Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: at the opening of the packaging, the swg (spring wire guide) was found kinked (bent).Another kit was used without incident.

Event Description

It was reported that: at the opening of the packaging the swg (spring wire guide) was found kinked (bent).Another kit was used without incident.

Manufacturer Narrative

Qn# (b)(4).Upon investigation of the returned sample, it was found that the malfunction was non-reportable; thus the initial mdr, submitted on 06/25/2019, was sent in error.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8732004
• MDR Text Key: 149113025
• Report Number: 1036844-2019-00731
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 23F18B0565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1