MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CU-22122-F

Device Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the package of the product was found damaged during preparation for hemodialysis.A new device was used.

Event Description

The customer reports that the package of the product was found damaged during preparation for hemodialysis.A new device was used.

Manufacturer Narrative

Qn#(b)(4).The customer returned one finished kit for evaluation.Visual examination confirmed the slit.The damage appeared consistent with a sharp object (scalpel, box cutter, etc.) coming in contact with the lidstock.The returned lidstock contained a slit about 50 mm in length.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "do not use if package has been previously opened or damaged." the customer report of a damaged lidstock was confirmed by complaint investigation of the returned sample.The lidstock contained a small slit that appeared consistent with a sharp object coming into contact with the kit (scissors, box cutter, etc.).A device history record review was performed with no relevant findings.Based on a complaint history review, this is the first and only customer report of a lidstock/sterility issue related to finished good lot#71f18c2594.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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9566006
• MDR Text Key: 180124363
• Report Number: 3006425876-2020-00066
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 12/24/2019

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: No Information
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F18C2594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1