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

Catalog Number	20019E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite extension set was occluded the following information was received by the initial reporter with the following verbatim.For the smartsite extension (bifuse) one port will flush and the second port is occluded and will not flush.Nurses were setting up for iv line placement, brand new set out of packet and priming for line set up.
Additional Manufacturer Narrative
It was reported that one of the ports would not flush.One photo was taken by the customer of the sample but does not confirm the issue.Due to no sample being returned a root cause could not be determined.A device history record review for model 20019e lot number 22125358 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material#: 20019e, batch#: 22125358.It was reported by the customer that for the smartsite extension ( bifuse) one port will flush and the second port is occluded and will not flush.Verbatim: for the smartsite extension ( bifuse) one port will flush and the second port is occluded and will not flush.Nurses were setting up for iv line placement, brand new set out of packet and priming for line set up.( see attached pictures for clarification).

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20737490
• Report Number: 9616066-2024-01694
• Device Sequence Number: 8287453
• Product Code: FPA
• UDI-Device Identifier: 07613203012010
• UDI-Public: (01)07613203012010(11)221209(17)251213(10)22125358
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 12/13/2025
• Device Catalogue Number: 20019E
• Device Lot Number: 22125358
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown