MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04301

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the doctor found the tip end of the catheter was abnormal (sunken) and the catheter could not be inserted.Another set was used to complete the procedure.Patient condition - fine.

Manufacturer Narrative

(b)(4).The customer returned one opened cvc kit with multiple components.Visual examination of the catheter revealed that the catheter tip was folded inward into the catheter body.Slight traces of biological material were observed on the catheter tip.No other defects or anomalies were observed.The catheter body from the juncture hub to the catheter tip measured 205.5mm, which is within the specification limits of 201.5-210.5mm per catheter product drawing.The inner and outer diameter of the catheter body were also within specification.A lab inventory long pin gage with a diameter of.032mm was inserted into the proximal end of the catheter.When the pin gage reached the catheter tip, resistance was felt.The pin gage was then used to push the folded portion of the tip out from the catheter body.After successfully completing this, the spring wire guide provided with the kit was inserted through distal end of the catheter.No resistance was felt.A device history record review was performed with no relevant findings.The ifu provided with the kit instructs the user "use vessel dilator to enlarge site as required" prior to the catheter insertion.The customer did not state whether the dilator was used.The ifu also warns the user "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested." the customer complaint that the catheter tip was deformed was confirmed through complaint investigation.The returned catheter showed signs of use in the form of biological material on the catheter tip.A long pin gage was used to push the folded portion of the catheter tip out from the catheter body.After successfully completing this, the spring wire guide provided with the kit was passed through the distal tip of the catheter with no resistance.The catheter passed all relevant dimensional testing.A device history record review was performed with no relevant findings to suggest a manufacturing issue.Based on the received sample, it was determined that unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the doctor found the tip end of the catheter was abnormal (sunken) and the catheter could not be inserted.Another set was used to complete the procedure.Patient condition - fine.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8124159
• MDR Text Key: 129029454
• Report Number: 3006425876-2018-00756
• 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: 11/19/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F16C1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1