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 02/15/2023

Event Type  malfunction  

Event Description

It was reported that "catheter ruptured on injection 12 ml @12ml/sec 540 psi".Multiple requests for information were made to the customer regarding confirmation of the issue with the catheter, when was the issue encountered (prior to patient use or during use), how the issue was resolved, if medical intervention was required, if the device caused any harm to the patient, and what the current condition of the patient is.All requests were unanswered by the customer.If further information is received, the complaint file will be updated.

Manufacturer Narrative

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

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

It was reported that "catheter ruptured on injection 12 ml @12ml/sec 540 psi".Multiple requests for information were made to the customer regarding confirmation of the issue with the catheter, when was the issue encountered (prior to patient use or during use), how the issue was resolved, if medical intervention was required, if the device caused any harm to the patient, and what the current condition of the patient is.All requests were unanswered by the customer.If further information is received, the complaint file will be updated.

• 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: 16515365
• MDR Text Key: 311068406
• Report Number: 3010532612-2023-00149
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F23A0020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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