MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESSORY KIT; INTRODUCER, CATHETER

Catalog Number	SA-09847
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the contamination shield with sheath adapter for temporary venous pacemaker was moist and noted to be filled with clear fluid.The side port is infusing with d5w and inotropes.Patient is stable hemodynamically.No patient harm reported.
Event or Problem Description
It was reported the contamination shield with sheath adapter for temporary venous pacemaker was moist and noted to be filled with clear fluid.The side port is infusing with d5w and inotropes.Patient is stable hemodynamically.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: the connection between sheath adapter and sheath must be tightly secured and examined routinely to minimize the risk of disconnection and possible air embolism, blood loss, or exsanguination." 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.

• Brand Name: ARROW ACCESSORY KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17828598
• Report Number: 9680794-2023-00709
• Device Sequence Number: 7182852
• Product Code: DYB
• UDI-Device Identifier: 00801902026149
• UDI-Public: 00801902026149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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
• Device Catalogue Number: SA-09847
• Device Lot Number: 13F22L0717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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: D5W AND INOTROPES; D5W AND INOTROPES
• Patient Sex: Unknown