MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER, SUBCLAVIAN

Catalog Number CS-15122-F

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports during insertion the physician noted a leak in the ars (syringe).The device was replaced without issue.

Manufacturer Narrative

Qn# (b)(4).The customer returned an ars and the product lid stock for evaluation.No other components were returned.Visual examination of the ars did not reveal any defects or anomalies.The handle of the ars was broken to examine the valve inside.The valve consists of two bi-lateral valve pieces and a spacer.No damage was observed to either of the valve pieces.There was evidence of the slits in the center of the valves.A vacuum leak test was performed on the ars 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 to its original position.The ars passes the test if the plunger returns to its original position, therefore, the sample passed the functional inspection.A laboratory introducer needle was attached to the returned syringe and water was aspirated into the ars.Water filled the syringe with no air bubbles entering.A device history record review was performed on the ars and no relevant manufacturing 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 and functional testing with water.No leaks were found during testing and the syringe was able to aspirate.No problem was found on the returned sample; therefore, no further action will be taken.

Event Description

The customer reports during insertion the physician noted a leak in the ars (syringe).The device was replaced without issue.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7432555
• MDR Text Key: 105542699
• Report Number: 3006425876-2018-00232
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F17H0647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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