MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	37262E
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer "¿iv tubing came disconnected from the chamber case while priming iv tubing.The tubing is bd smartsite extension set 2 needle free valves fluid flowing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.H3: see h.10.
Event or Problem Description
It was reported while using bd alaris smartsite extension set the connection was loose and leakage occurred.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: ¿iv tubing came disconnected from the chamber case while priming iv tubing.The tubing is bd smartsite extension set 2 needle free values ref.37262e alaris product.This is the second time this has happened with fluid flowing all over floor.".Was there any harm or injury to the patient, health care provider, or any other person? no.Was there a delay of or change in the course of treatment due to the event? please provide any available details.Delay in providing care as dealing with clean up and containment of failure.If not answered in question #2, what was the medication administered to the patient? no.Is the event date known? (b)(6) 2023.Is the product code/sku known? no.Is the lot number known? no.Is this sample available for investigation? unsure, attempting to obtain if not, is a photo sample available? no.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16746412
• Report Number: 9616066-2023-00698
• Device Sequence Number: 3276922
• Product Code: FPA
• UDI-Device Identifier: 50885403235274
• UDI-Public: (01)50885403235274
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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: Other
• Device Model Number: 37262E
• Device Catalogue Number: 37262E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown