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

Catalog Number	AI-07135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use on a patient, the catheter "ruptured during a case" distal to the connection hub.As a result, the catheter was removed and a 2nd catheter was inserted, however the same issue occurred.A 3rd catheter was then inserted and again the same issue occurred.All 3 catheters were inserted at the same insertion site.No patient harm or injury.The patient status is reported as "stable".See associated mdrs #3010532612-2023-00450 and #3010532612-2023-00451.
Event or Problem Description
It was reported that during use on a patient, the catheter "ruptured during a case" distal to the connection hub.As a result, the catheter was removed and a 2nd catheter was inserted, however the same issue occurred.A 3rd catheter was then inserted and again the same issue occurred.All 3 catheters were inserted at the same insertion site.No patient harm or injury.The patient status is reported as "stable".See associated mdrs #3010532612-2023-00450 and #3010532612-2023-00451.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of catheter body ruptured in use was not able to be confirmed as the product was not returned for investigation.The customer returned an original packaging pouch for a 5fr.80cm berman catheter was returned without the actual device along with the sample in a cardboard box (inp-1 through inp-4).A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend for complaints of this nature.Additional information received on 30 aug 2023 states that "all three catheter ruptured during injection, at the same area, on the catheter, just below the hub.The injections were all the same settings.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Common Device Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17443793
• Report Number: 3010532612-2023-00449
• Device Sequence Number: 2597974
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 08/31/2024
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F23C0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown