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

Model Number	10037032
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a 10037032 sample was not available for investigation; however, the customer indicated the complaint sample was from lot 21109297.The feedback provided by the customer indicates the burette sets had separated at the joint of the burette chamber and the white cap.No further information was available to assist the investigation in this instance.As part of the investigation the customer provided a photograph of their experience; analysis of the photograph confirmed the customer's experience as the white cap at the base of the burette had separated from the burette chamber.A closer inspection of separated joint could not identify any obvious signs of residual solvent.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the burette during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 21109297 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 10037032 set in the past 12 months.
Event or Problem Description
It was reported that 5 bd alaris smartsite gravity burette sets experienced component separation.The following information was provided by the initial reporter: it was reported that 5 units of burettes with the same lot number were identified to have come apart between the chamber and base.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BURETTE 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: 15917647
• Report Number: 9616066-2022-01851
• Device Sequence Number: 4468190
• Product Code: FPA
• UDI-Device Identifier: 50885403244054
• UDI-Public: 50885403244054
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K780130
• 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
• Report Date (Section B): 11/22/2022

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: 10/04/2024
• Device Model Number: 10037032
• Device Catalogue Number: 10037032
• Device Lot Number: 21109297
• 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: 11/11/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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