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

Catalog Number ES-04301

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The ars was found leaking during usage on the patient.

Event Description

The ars was found leaking during usage on the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one arrow raulerson syringe (ars), an introducer needle, swg, dilator, s-l catheter and lidstock for evaluation.Visual examination of the ars did not reveal any anomalies or defects.After the ars failed the vacuum leak functional test, the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.A small puncture hole was observed in the center of both valve pieces.There was evidence of the slits in the center of the valves.No defects or anomalies were observed in any of the other returned components.A vacuum leak test was performed on the samples 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 into a position = 1cc from the starting position.The ars passes the test if the plunger returns to a position = 1cc; therefore, the sample failed functional inspection.A push leak test was also performed on the ars 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 initially felt, but the plunger body was able to move to the bottom of the syringe; therefore, the sample failed the push leak test.A device history record review was performed, and no relevant findings were identified.The issue of the ars leaking was confirmed during functional testing of the returned sample.The returned syringe failed both the vacuum testing and the push testing.Examination of the plunger seal and the valve revealed small puncture hole in both of the valve halves.A device history record review did not reveal any relevant findings.A capa has been initiated to further investigate this complaint issue and has determined a root cause of manufacturing; corrective actions have not yet been implemented.Teleflex will continue to monitor and trend reports of this nature.

• 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: 10356027
• MDR Text Key: 201614901
• Report Number: 3006425876-2020-00695
• 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: 07/23/2020

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: 01/24/2022
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F17A1562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1