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

Catalog Number AI-07165

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9273065
• MDR Text Key: 180031242
• Report Number: 3010532612-2019-00384
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902004550
• UDI-Public: 00801902004550
• Combination Product (y/n): N
• PMA/PMN Number: K823433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: AI-07165
• Device Lot Number: 16F19H0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1