MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ACCESS TRAY; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number PI-01451-SS

Device Problems Crack (1135); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the clinician inserted the introducer needle, threaded the guide wire, removed the needle, and placed the sheath/dilator over the wire without issue.When it was time to thread the catheter through the sheath the picc would not advance half way through.The clinician tried to re-advance the guide wire to see what happened and the wire would no longer advance as well.As a result, the sheath was removed and the clinician observed the sheath had a kink and a small tear at the kink.There was no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report that the sheath body was damaged and the picc would not pass through was confirmed.Returned were a dilator and a peel-away sheath.Note that this kit is an access tray and does not contain a catheter.With the unaided eye, there was damage to the sheath body located 2 cm from the hub.Under microscopic examination, the body was partially split and the body was creased from being bent.As received the sheath body was straight and the dilator would pass through sheath without resistance.When the sheath body was bent near a 45 degree angle at the crease, the dilator would stop and push out the side of the sheath.A device history record review was performed on the sheath and did not reveal any manufacturing related issues.Based on the damage to the sheath and the information reported, operational context caused or contributed to this issue.No further action will be taken.

• Brand Name: ACCESS TRAY
• Type of Device: PERIPHERALLY INSERTED CATHETER PRODU
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6002685
• MDR Text Key: 56596739
• Report Number: 9680794-2016-00173
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

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: 01/31/2021
• Device Catalogue Number: PI-01451-SS
• Device Lot Number: 14F16A0564
• Other Device ID Number: 00801902095039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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