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 Insufficient Information (4580)

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "catheter ruptured on injection 12 ml at 12ml/sec 540 psi".Additional information states, "none of the incidences caused any harm.All but one worked successfully with hand injections, but all failed at the first power injection.There was no harm to anyone involved.The catheters were all removed without incident and the procedures were completed with alternative catheters".

Event Description

Reported as "catheter ruptured on injection 12 ml at 12ml/sec 540 psi".Additional information states, "none of the incidences caused any harm.All but one worked successfully with hand injections, but all failed at the first power injection.There was no harm to anyone involved.The catheters were all removed without incident and the procedures were completed with alternative catheters".

Manufacturer Narrative

Qn # (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.

• 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: 16329116
• MDR Text Key: 309132051
• Report Number: 3010532612-2023-00054
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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