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

Model Number	10014918
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
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 when using the bd alaris syringe module syringe admin.Set the device experienced component separation.The following information was provided by the initial reporter.The customer stated: when i went to re-trace the line i noticed the pressure disk was in the sensor but the tubing was disconnected from the disk right below the disk.
Additional Manufacturer Narrative
H6: investigation summary: the customer reported the tubing disconnected and returned one used set of material #10014918.The sample was clearly disconnected at the pressure sensing disc, and the complaint is verified.The root cause of the separation was a lack of solvent applied during assembly.Analysis under the microscope found the lack of solvent.A device history record review for model 10014918 lot number 20076511 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 15jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported when using the bd alaris syringe module syringe admin.Set the device experienced component separation.The following information was provided by the initial reporter.The customer stated: when i went to re-trace the line i noticed the pressure disk was in the sensor but the tubing was disconnected from the disk right below the disk.

• Brand Name: BD ALARIS SYRINGE MODULE SYRINGE ADMIN. 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13006210
• Report Number: 9616066-2021-52596
• Device Sequence Number: 19264001
• Product Code: FPA
• UDI-Device Identifier: 50885403233942
• UDI-Public: 50885403233942
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 07/14/2023
• Device Model Number: 10014918
• Device Catalogue Number: 10014918
• Device Lot Number: 20076511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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