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

Catalog Number	4030B-07T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite texium low sorbing secondary set separated the following information was received by the initial reporter with the following verbatim the filter portion of the secondary set fell off during verification.This is the 2nd item we've had like this, but i am unsure if it is the same or different lot.Patient here longer than necessary, more work involved than necessary, waste.Item#4030b-07t.Lot#23039083.
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
No additional information was provided.Material #: 4030b-07t.Batch#: 23039083.It was reported by customer that the filter portion of the secondary set fell off during verification.This is the 2nd item we've had like this, but i am unsure if it is the same or different lot.Patient here longer than necessary, more work involved than necessary, waste.Verbatim: rcc received a complaint via mail.The filter portion of the secondary set fell off during verification.This is the 2nd item we've had like this, but i am unsure if it is the same or different lot.Patient here longer than necessary, more work involved than necessary, waste.Item#4030b-07t.Lot#23039083.
Additional Manufacturer Narrative
It was reported by customer that the filter portion of the secondary set fell off during verification.One sample was received for quality evaluation.The sample was visually examined for any damages or abnormalities.Visual investigation revealed that the filter separated from the tubing.Further evaluation under magnification shows that the surfaces of the filter inlet port and the inner surface of the infusion set tubing show an insufficient amount of bonding solvent.The customer complaint of separation was confirmed.Further issues were not identified on the infusion set.The root cause for the issue reported by the customer is an insufficient amount of bonding solvent at the union location between the infusion set tubing and the the filter inlet port.The investigation had been moved to manufacturing for further analysis.After investigation at the manufacturing facility, the potential root cause for separation between tubing sleeve and filter could be related to lack of solvent due to using an incorrect solvent application method by the assembler.A device history record review for model 4030b-07t lot number 23039083 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15mar2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS SMARTSITE TEXIUM LOW SORBING SECONDARY 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: 18827279
• Report Number: 2016493-2024-18013
• Device Sequence Number: 3008670
• Product Code: FPA
• UDI-Device Identifier: 50885403240865
• UDI-Public: (01)50885403240865
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 05/17/2024

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: 03/15/2026
• Device Catalogue Number: 4030B-07T
• Device Lot Number: 23039083
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown