MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

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

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports the swg (spring wire guide) was found kinked prior to the patient use.

Manufacturer Narrative

(b)(4).The customer returned one cvc kit containing a spring wire guide (swg) within the advancer tubing, catheter, ars, catheter over needle, and introducer needle for evaluation.No signs of use were evident on any of the returned components.The guide wire cap was not returned with the assembly.Visual examination of the returned swg confirmed the kink in the guide wire body.During normal assembly, the kink in the coil of the guide would have been located inside the protective tube assembly, protecting it from damage.No damage was noted on the tube assembly.The distal j-bend was intact.Both welds appeared spherical and fully formed.The kink in the guide wire body was located at 402 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 0.795 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was advanced through the returned ars, 18 ga introducer needle, and 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.A device history record review was performed and 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 report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.The returned guide wire had one kink in its body.The swg passed all relevant dimensional and functional inspection.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.During normal packaging, the portion of the guide wire that kinked would have been located inside the protective tube assembly, protecting it from damage.Therefore, it cannot be confirmed when the guide wire was kinked.The root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the swg (spring wire guide) was found kinked prior to the patient use.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10372967
• MDR Text Key: 201857806
• Report Number: 3006425876-2020-00703
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/20/2020
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F18M1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1