MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 16 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-42703-1A

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the physician had trouble threading the catheter over the needle due to the kinking of the wire.No patient harm reported.

Manufacturer Narrative

(b)(4).The customer returned one lidstock, dilator, guide wire, and catheter for evaluation.The guide wire was returned advanced through the catheter.The sample contained signs of use in the form of biological material.Visual examination of the guide wire revealed three major bends near the distal end.The other components were visually inspected with no defects or anomalies.The guide wire contained three bends 17, 29, and 102 mm from the distal end.The total length and outer diameter of the guide wire were measured and were found to be within specification.The returned catheter body measured 169 mm, which is also within specification.The returned guide wire was able to pass through the returned catheter with a significant amount of resistance.All three lines of the catheter were flushed and no inter lumen crossover or resistance was detected.A manual tug test confirmed both welds of the guide wire were fully intact.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "if resistance is encountered, withdraw catheter relative to guidewire about 2-3 cm and attempt to remove guidewire.If resistance is again encountered, remove guidewire and catheter simultaneously." the reported complaint of guide wire damage was confirmed by complaint investigation.The guide wire contained three bends.The guide wire and catheter passed all relevant dimensional inspection.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the physician had trouble threading the catheter over the needle due to the kinking of the wire.No patient harm reported.

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 16 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7378603
• MDR Text Key: 103799977
• Report Number: 1036844-2018-00105
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CDC-42703-1A
• Device Lot Number: 23F17G0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1