MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 8"; CATHETER, PERCUTANEOUS

Catalog Number AK-04301-J

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after catheter insertion, the user exerted negative pressure on the catheter, but blood could not be pulled in a syringe.Therefore, the catheter was replaced by a new one.

Manufacturer Narrative

Qn#(b)(4).The customer returned the lid stock, introducer needle, and arrow raulerson syringe (ars) from an ak-04301-j kit for evaluation.Visual examination of the syringe and introducer needle did not reveal any defects or anomalies.A vacuum leak test was performed on the syringe per inspection procedure.With the plunger body at the bottom of the syringe, the tip of the ars was occluded and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released and it snapped back into a position = 1cc from the starting position.The ars passes the test if the plunger returns to a position = 1cc; therefore, the sample passed the functional inspection.A push leak test was also performed on the syringes per inspection procedure.With the plunger body fully out of the barrel, the tip of the ars was occluded and the plunger was pushed into the barrel.Resistance was felt and the plunger body was not be able to move to the bottom of the syringe, therefore, the sample passed the push leak test.The syringe was used to draw and aspirate water.No issues were identified.The report that the ars leaked could not be confirmed through functional testing of the returned sample.The ars sample passed the vacuum leak test, the push leak tes, and functional testing with water.No leaks were found during testing and the syringe was able to aspirate.The reported complaint issue could not be reproduced with the returned samples.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that after catheter insertion, the user exerted negative pressure on the catheter, but blood could not be pulled in a syringe.Therefore, the catheter was replaced by a new one.

• Brand Name: ARROW CVC KIT: 16 GA X 8"
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7659117
• MDR Text Key: 113048446
• Report Number: 3006425876-2018-00415
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F17F1205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1