MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The md found that the swg (spring wire guide) was bent.The md judged it as a defective product and used new product.

Manufacturer Narrative

(b)(4).The customer returned one spring wire guide (swg), 3-l cvc catheter, and catheter over needle for evaluation.No signs of use were noted on any of the returned components.The guide wire advancer assembly was not returned, indicating the customer had taken the wire out of its protective tubing.Visual examination of the guide wire revealed one kink in the guide wire body at the distal end.Microscopic examination confirmed both welds were present and spherical.The kink in the guide wire body was located at 561 mm from the proximal end.The total length of the guide wire measured to be 602 mm which is within specifications of 596-604 mm per swg product drawing.The outer diameter of the guide wire measured to be 0.796 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was advanced through a lab inventory ars, 18 ga introducer needle, and returned catheter to functionally test.The swg passed through all three with minimal resistance.A manual tug test confirmed both welds were fully intact on the guide wire.The swg was inserted into a lab inventory guide wire assembly.It was noted that the kink was located over the thumb guide and not in the protective tubing.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with the kit informs the user, "do not use if package has been previously opened or 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, and a device history record review was performed based on sales history with no relevant findings.The guide wire assembly was not returned, indicating that the customer had handled the wire.The area of the swg that was kinked would not have been protected by the assembly tubing during manufacturing and 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 (spring wire guide) was bent.The md judged it as a defective product and used new product.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10257942
• MDR Text Key: 198723959
• Report Number: 3006425876-2020-00591
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-25703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1