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

Catalog Number	20127E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
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 had foreign matter the following information was received by the initial reporter with the following verbatim: rcc received a complaint via phone.Pir attached.Primary rn attempted to run fluid through iv tubing for lipids.Lipids would not run through line.Rn check to make sure all clamps were undone, and fluids were still not running through tubing.Found blue plastic barrier in tube.Looks like a manufacturing error.
Additional Manufacturer Narrative
It was reported by customer that lipids would not run through line.One sample of material number 20127e was submitted for quality evaluation.Visual examination of the sample was conducted and no damages or abnormalities were identified in the tubing set.The set was then attempted to be primed.During priming, flow was not established throughout the entire sample.Further inspection of the sample, under magnification, indicates that there is a blockage at the inlet port of the filter.The customer complaint of flow issues - fluid blockage was confirmed.Further investigation was conducted at the manufacturing facility.After investigation, the possible root cause of occlusion between tubing and filter could be related to an excess of solvent due to an incorrect application of solvent by assembler.A quality alert was created and communicated to the production personnel to reinforce the correct application method to avoid occlusion.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
Material #: 20127e.Batch #: unknown.It was reported by customer that lipids would not run through line.Rn check to make sure all clamps were undone, and fluids were still not running through tubing.Found blue plastic barrier in tube.Verbatim: rcc received a complaint via phone: primary rn attempted to run fluid through iv tubing for lipids.Lipids would not run through line.Rn check to make sure all clamps were undone, and fluids were still not running through tubing.Found blue plastic barrier in tube.Looks like a manufacturing error.Product code: 20127e.

• 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: 20045220
• Report Number: 9616066-2024-01214
• Device Sequence Number: 7955629
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 02/06/2025

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 Catalogue Number: 20127E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown