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

Catalog Number	20038E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: just wanted to pass this along as this is the first i am having an issue with recently o#: 23331 incident: (b)(4): told we had an isse with 3 trifuses.Two of the lumens would flush, bu the 3rd would not flush and was not allowing flow when flushing.Below is the ref#: additional information received: spoke with customer and she confirmed that there was only one occurrence and the reference of "3 trifuses" refers to the name the product is referred to within the organization and not the number of occurrences.No sample is available.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer the 3rd lumen would not flush and was not allowing flow when flushing.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 20038e lot number 22115429 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: just wanted to pass this along as this is the first i am having an issue with recently o#(b)(4) incident (b)(4): told we had an isse with 3 trifuses.Two of the lumens would flush, bu the 3rd would not flush and was not allowing flow when flushing.Below is the ref# additional information received spoke with customer and she confirmed that there was only one occurrence and the reference of "3 trifuses" refers to the name the product is referred to within the organziation and not the number of occurrences.No sample is available.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16531506
• Report Number: 9616066-2023-00417
• Device Sequence Number: 20365224
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: (01)07613203011976
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 03/17/2023

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 Expiration Date: 11/18/2025
• Device Catalogue Number: 20038E
• Device Lot Number: 22115429
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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
• Patient Sex: Unknown