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
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
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported fluid blockage, and returned one photo of the set, of material 20019e, lot 22125358.The photo was examined, and the complaint of flow issues was verified.There was no flow through the set, (through one of the smart sites in the bifuse), the other smart site was able to infuse.The issue was forwarded to manufacturing.The manufacturing site was unable to identify the root cause for smart site occlusion, due to insufficient evidence from photo investigation.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.The smart site component was manufactured before process improvements that addressed occlusion, which includes a quality alert issued 19jul2023 to communicate and reinforce proper fluorosilicone assembly procedure to personnel.In addition, a fixture for fluorosilicone weighing, which lubricates the smart site piston, was implemented 23jun2023.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• 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: 20736761
• Report Number: 9616066-2024-01696
• Device Sequence Number: 8287428
• 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): 12/19/2024

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: 12/19/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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