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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris secondary set experienced component separation.The following information was provided by the initial reporter: spike tunnel snapped off the iv bag.The event occurred on (b)(6) 2023 during use.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary the photos received of the 111448964 device were of the packaging and though the separation described cannot be seen in photos, the drip chamber separation failure is a known issue and the complaint can be verified.The root cause of this issue can be traced to improper application of solvent (or glue) used to join the drip chamber to the tubing during that point of assembly.A trend for the drip chamber separation issue has been identified for this product line.We have funded a project to examine how to further increase the robustness of the 111448964 device and prevent future occurrences of this type.As part of the action plan, changes to the tubing to drip chamber assembly are in the process of being implemented.Customer complaint trends will also continue to be evaluated on a monthly basis.A device history record review for model 11448964 lot number 22119334 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd alaris secondary set experienced component separation.The following information was provided by the initial reporter: spike tunnel snapped off the iv bag.The event occurred on 01 mar 2023 during use.There was no patient involvement.
Event or Problem Description
It was reported that the bd alaris secondary set experienced component separation.The following information was provided by the initial reporter: spike tunnel snapped off the iv bag.The event occurred on 01 mar 2023 during use.There was no patient involvement.
Additional Manufacturer Narrative
Correction after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 9616066-2023-00641 was sent in error.This device is not manufactured by bd.

• 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: 16687132
• Report Number: 9616066-2023-00641
• Device Sequence Number: 17670180
• 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,Followup
• Report Date (Section B): 06/20/2023

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: 11/19/2025
• Device Catalogue Number: 11448964
• Device Lot Number: 22119334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 06/20/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/30/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2022
• 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