MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN914732

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

While inserting the catheter, the tip of the dilator broke in the patient's jugular vein.There was no clinical consequence for the patient because the broken tip did not enter the bloodstream.The patient's condition is reported as fine.No report of a required medical intervention.

Event Description

While inserting the catheter, the tip of the dilator broke in the patient's jugular vein.There was no clinical consequence for the patient because the broken tip did not enter the bloodstream.The patient's condition is reported as fine.No report of a required medical intervention.

Manufacturer Narrative

(b)(4).Additional information received from the customer: "there was no a medical intervention necessary because the small piece of plastic did not detached completely.This incident was reported as a precautionary measure as the consequences could have been serious." the customer returned two photos confirming the complaint of a damaged dilator tip.Visual inspection of the photos revealed a spring wire guide (swg) inserted into a dilator and the dilator tip had separated from the dilator body.The customer returned one merit medical dilator with a swg inserted and a lidstock for evaluation.The sheath was not returned.Visual inspection of the dilator confirmed the dilator tip was damaged.The dilator tip had completely separated from the body.The swg was also noted to be kinked near the location of the dilator separation.The two sections of the dilator returned measured 0.25" and 8.25" totaling 8.5", which is within specifications of 8.49-8.51" per sheath/dilator product drawing.The outer diameter of the dilator measured 0.2101" which is within specifications of 0.209-0.212" per sheath/dilator product drawing.The inner diameter at dilator tip measured 0.038" which is within specifications of 0.038-0.039" per sheath/dilator product drawing.The returned dilator was functionally tested with a lab inventory merit medical sheath per the instructions for use (ifu).The ifu provided with this kit states, "insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly." the dilator was inserted into the sheath with no issues.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the complaint of a damaged dilator tip was confirmed by complaint investigation of the returned sample and the customer photos.The dilator tip was completely separated from the dilator body.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample returned, the root cause of this investigation is supplier related.A non-conformance request has been initiated to further investigate the separated dilator tip.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12837907
• MDR Text Key: 281224867
• Report Number: 9680794-2021-00611
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902157895
• UDI-Public: 10801902157895
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN914732
• Device Catalogue Number: CS-15272-VFIE
• Device Lot Number: 13F20K0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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