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

Catalog Number	11448964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
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 secondary set broke below drip chamber.The following information was provided by the initial reporter: (b)(6): secondary line broke when checked, broke below drip chamber.Lot (10)22103532 - line does not contain any drug or solution (non-cytotoxic).
Additional Manufacturer Narrative
H6: investigation summary: one sample was received and tested by our quality team.The tubing was separated from the drip chamber upon receipt.After visual analysis under microscope was performed, the tubing was completely lacking solvent.The root cause of separation failure was an inadequate application of solvent during that portion of the assembly process.The manufacturer has been notified of this failure.A trend for the drip separation issue has been identified for this product line.We have funded a project to examine how to further increase the robustness of the 11448964 device and prevent future occurrences of this type.As part of the action plan, changes to the drip chamber to tubing assembly are in the process of being implemented.A device history record review for model 11448964 lot number 22103532 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris secondary set broke below drip chamber.The following information was provided by the initial reporter: jan 30: secondary line broke when checked, broke below drip chamber.Lot (10)22103532 - line does not contain any drug or solution (non-cytotoxic).

• Brand Name: BD ALARIS 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16519277
• Report Number: 9616066-2023-00398
• Device Sequence Number: 14291256
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: (01)10885403234743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 10/07/2025
• Device Catalogue Number: 11448964
• Device Lot Number: 22103532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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