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 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received by the manufacturer, however the evaluation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the complaint investigation.

Event Description

Customer complaint alleges the ars syringe could not aspirate.Alleged issue was detected during insertion.It was reported there was a delay in therapy.The issue was resolved with a new kit.It was reported there were no patient complications.

Manufacturer Narrative

(b)(4).The customer returned an arrow-raulerson syringe (ars) and an introducer needle for investigation.The ars and introducer needle were visually examined and no defects or anomalies were observed.The syringe was vacuum tested per inspection procedure by occluding the tip, pulling the plunger back, and releasing the plunger.The plunger did not return to its original position.The plunger was rotated 45 degrees clockwise and the test was repeated.The plunger did not return to its original position again.The syringe was used to draw water from a 200 ml measuring cup.The syringe did not fill completely with water when the plunger was extended to its maximum.A device history record review was performed and no relevant findings were identified.The customer reported issue that the ars would not aspirate was confirmed during the sample investigation.Functional testing was performed on the returned ars syringe and it was confirmed that the seal was faulty.A non-conformance request has been generated to further investigate this issue.

Event Description

Customer complaint alleges the ars syringe could not aspirate.Alleged issue was detected during insertion.It was reported there was a delay in therapy.The issue was resolved with a new kit.It was reported there were no patient complications.

• 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 INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7000898
• MDR Text Key: 91364926
• Report Number: 1036844-2017-00393
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 23F17D0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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