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 Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports: hospital reports that cover on the tray has a gap without using on patient.

Manufacturer Narrative

(b)(4).The customer returned one unopened hemodialysis kit for evaluation.Visual inspection of the kit confirmed the slit in the lidstock.The slit had the appearance of damage caused by a sharp instrument (i.E.Knife, box cutter).A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with this kit instructs the user, "do not use if package has been previously opened or damaged." the report of a sterility issue in the kit packaging was confirmed through the customer photo and the complaint investigation of the returned sample.Visual analysis revealed a slit in the top of the lidstock that was consistent with damage caused by a sharp instrument (i.E.Box cutter).A device history record review was performed with no relevant findings.Based on the customer description that the kit was found damaged, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: hospital reports that cover on the tray has a gap without using on patient.

• 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
• MDR Report Key: 9848537
• MDR Text Key: 184071706
• Report Number: 3006425876-2020-00239
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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 Operator: Health Professional
• Device Expiration Date: 02/03/2021
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F19B1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1