MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number IPN917235

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reported as "issue with 5fr x 80cm berman".The report states that "[the catheters] all failed on their first power injection.Some were used for hand angiography before power injection without incident.One received enough contrast that no further angiograms were not required, the others received angiograms with a different catheter.No medical intervention was required.No harm was done.No impact other than a slight time delay to get replacement catheters and clean the splashed contrast off the drapes and equipment covers".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "issue with 5fr x 80cm berman".The report states that "[the catheters] all failed on their first power injection.Some were used for hand angiography before power injection without incident.One received enough contrast that no further angiograms were not required, the others received angiograms with a different catheter.No medical intervention was required.No harm was done.No impact other than a slight time delay to get replacement catheters and clean the splashed contrast off the drapes and equipment covers".

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16407559
• MDR Text Key: 309870634
• Report Number: 3010532612-2023-00114
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22L0062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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