MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 8 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number AK-15802-J

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while the user was attempting to confirm return blood after catheter insertion, air was aspirated in the syringe.As a result the user replaced the kit.

Manufacturer Narrative

(b)(4).The customer returned an arrow raulerson syringe (ars) and an introducer needle for evaluation.Visual examination of the ars and introducer needle did not reveal any defects or anomalies.After the ars failed the functional inspection, the handle was broken to examine the valve inside.The valve consists of two bi-lateral valve pieces and a spacer.A puncture hole was observed in the center of the top valve and bottom valve.There was evidence of the slits in the center of the valves.A vacuum leak test was performed on the ars 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 did not snap back in to a position = 1cc after the ars was tested.The ars passes the test if the plunger returns to a position = 1cc; therefore, the sample did not pass the functional inspection.Water was aspirated into the returned ars.Water and air filled the syringe with a significant amount of air bubbles entering.A lab inventory 0.032" guide wire was passed through the valve in the ars handle and no resistance was met.Manufacturing engineering was consulted in an effort to determine a possible root cause for the hole observed in the valve.It was noted that the only way the defect could be replicated was by passing a swg through the ars very fast and inconsi derately.All ars syringes are 100% tested for vacuum after assembly process and the returned syringes would not have passed this in-process inspection.A device history record review was performed on the ars and no relevant manufacturing issues were identified.The customer reported issue of the ars syringe leaking was confirmed during functional testing of the returned sample.Functional testing was performed on the returned ars syringe and it was confirmed that the seal was faulty.Examination of the plunger seal and the valve revealed a small puncture hole in both of the valve halves.Although the ars did not meet functional requirements and damage to the valve was observed, a probable root cause could not be determined as the ars components are 100% vacuum tested after assembly and the defect could not be replicated within standard manufacturing processes.Teleflex will continue to monitor and trend reports of this nature.

Event Description

It was reported that while the user was attempting to confirm return blood after catheter insertion, air was aspirated in the syringe.As a result the user replaced the kit.

• Brand Name: CVC KIT: 2-LUMEN 8 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7613589
• MDR Text Key: 111475168
• Report Number: 3006425876-2018-00416
• 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: 06/11/2018

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: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: AK-15802-J
• Device Lot Number: 71F17F2107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1