MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25854-E

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

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The md found that the swg was bent.The md judged it as a defective product and used new product.

Manufacturer Narrative

Qn# (b)(4).The customer returned one swg in the advancer tubing, a 4-l catheter, dilator, ars syringe, a needle, a catheter over needle, a transduction probe, a clamp, a fastener and three dust caps for evaluation.The packaging was not returned.The straightener tube and end cap from the swg assembly were also not returned.There was no evidence of use on any of the returned components.Visual examination of the returned swg confirmed the guide wire is kinked near the distal end.This section would not be protected if the straightener tube and end cap were to become dislodged during shipping, indicating that the guide wire may have been damaged during shipment.The distal j-bend was intact.Both welds appeared spherical and fully formed.The returned guide wire was kinked 584 mm from the proximal end.The total length of the guide wire measured to be 603mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.791 mm which is within specifications of 0.788-0.826 mm per product drawing.The undamaged portions of the returned wire guide passed through the returned 18 ga introducer needle, ars syringe, dilator & distal lumen of the catheter with minimal resistance.A manual tug test confirmed the distal and proximal welds were fully attached.The instructions for use (ifu) provided with the kit informs the user: "read all package insert warnings, precautions and instructions prior to use.Failure to do so may result in severe patient injury or death" "do not use if package is damaged." the customer report of guide wire damage before use was confirmed by complaint investigation of the returned sample.The sample passed all relevant dimensional and functional testing.The guide wire was returned within its advancer tubing; however the end cap and straightener tube were not attached or returned.The tubing showed no kinks or stress marks.The portion of the guide wire that kinked would not be protected by the advancer tubing if the straightener tube and end cap were to become dislodged during shipping.Based on the condition of the guide wire and the report that the damage was observed before use, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The md found that the swg was bent.The md judged it as a defective product and used new product.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10400996
• MDR Text Key: 202706884
• Report Number: 3006425876-2020-00717
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K962577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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 Catalogue Number: CS-25854-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.