MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 5 80CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07165
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during incoming inspection/inventory review that the packaging was found to be incorrect.The customer noted that the packaging on the thermodilution balloon catheter had a red packaging vs.Blue packaging.The label and the catheter were correct but the pouch was incorrect.There was no reported patient involvement or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation and confirmed the reported complaint.Upon return, a berman angiographic balloon catheter packaging pouch was noted with a thermodilution balloon catheter label.The device inside the pouch was confirmed to be a thermodilution balloon catheter.The reported complaint is isolated.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported that during incoming inspection/inventory review that the packaging was found to be incorrect.The customer noted that the packaging on the thermodilution balloon catheter had a red packaging vs.Blue packaging.The label and the catheter were correct but the pouch was incorrect.There was no reported patient involvement or consequence.

• Brand Name: CATH PKGD: THERMISTOR 5 80CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9273065
• Report Number: 3010532612-2019-00384
• Device Sequence Number: 1573152
• Product Code: DYG
• UDI-Device Identifier: 00801902004550
• UDI-Public: 00801902004550
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K823433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: AI-07165
• Device Lot Number: 16F19H0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1