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); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 bd alaris smartsite gravity burette sets experienced leakage, and component separation.The following information was provided by the initial reporter: burette leaks and then the bottom of burette set came off.
Event or Problem Description
It was reported that 2 bd alaris smartsite gravity burette sets experienced leakage, and component separation.The following information was provided by the initial reporter: burette leaks and then the bottom of burette set came off.
Additional Manufacturer Narrative
H.6.Investigation: a 10037032 product was not available for investigation; and the lot number was not provided.As part of the feedback the customer provided photographs of the affected product, analysis of the photographs confirmed the customer's experience with separation of the base cap of the burette visible.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 base of the burette during the assembly process; this is a manually assembled joint and therefore the customer's experience is likely to have occurred due to human error.

• 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: 13771678
• Report Number: 9616066-2022-00232
• Device Sequence Number: 3967154
• 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,Followup
• Report Date (Section B): 03/17/2022

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 Model Number: 10037032
• Device Catalogue Number: 10037032
• Device Lot Number: UNKNOWN
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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