MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CHRONIC HEMODIALYSIS PRODUCTS

Catalog Number CS-15282-VSP

Device Problems Material Rupture (1546); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in the surgery department.During insertion, the smart seal peel away sheath tears and does not peel smoothly.The tear is very rigid and looked forced.It was difficult to remove the sheath, however, it was completely removed.There was no patient death or complications reported.Follow up information confirmed that the sheath did not tear as it is supposed to.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report that the smartseal sheath did not tear properly was confirmed.Two pieces of a separated smartseal sheath were returned.Visual examination revealed one section consists of a 31 cm section of catheter body attached to the hub.Microscopic inspection found that the score line started 5 mm from the end of the catheter body and appeared shallow.The catheter body did not peel along the score line.The other piece was an 11.5 cm long section of catheter body with an uneven tear observed on 5.5 cm of the length.A device history record review was performed and did not reveal any manufacturing related issues.Since the smartseal sheath is a purchased item, the probable cause of this issue is supplier related.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Type of Device: CHRONIC HEMODIALYSIS PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5513483
• MDR Text Key: 40800504
• Report Number: 1036844-2016-00166
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 23F15H0744
• Other Device ID Number: 00801902043924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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