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

Model Number	10794983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris extension set there were components missing.There was no report of patient impact.The following information was provided by the initial reporter: no white clip on one section of tubing.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of set missing a clamp was received from the customer.Photos of the set and packaging were received for investigation.In the photo, the set was observed to be missing a white slide clamp.The customer complaint was confirmed.A device history record review for model 10794983 lot number 22109171 was performed.The search showed that a total of (b)(4) in 1 lot number were built on 08oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being received, a full investigation could not be performed, and a root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-may-2023.H6: investigation summary: a complaint of set missing a clamp was received from the customer.Photos of the set and packaging were received for investigation.In the photo, the set was observed to be missing a white slide clamp.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The clamp was missing.A device history record review for model 10794983 lot number 22109171 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.The root cause for the defect is an error during the assembly process.
Event or Problem Description
It was reported while using bd alaris extension set there were components missing.There was no report of patient impact.The following information was provided by the initial reporter: no white clip on one section of tubing.

• Brand Name: BD ALARIS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16740435
• Report Number: 9616066-2023-00690
• Device Sequence Number: 6596979
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: (01)50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 07/06/2023

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: 10/08/2025
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: 22109171
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2022
• 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