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

Catalog Number	10037032
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bottom of the bd alaris¿ smartsite¿ gravity burette set separated from the chamber of the burrette and leaked.Additionally, 2 other sets also separated from the chamber during use.The following information was provided by the initial reporter: "we have had another incidence of the bottom popping off the chamber of the burette on these sets ¿ one exploded in use and our lead at has bought me another two faulty sets.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 05-may-2023.H6: investigation summary one 10037032 sample from lot 21109297 was received in sealed packaging for investigation.The feedback provided by the customer suggests the white cap had separated from the base of the burette.As part of the feedback the customer provided photographs; analysis of the photographs in addition to a visual inspection of the returned sample confirmed the customer's experience as the set was received separated at the base of the burette.A close inspection of the burette base reveals a lack of solvent residue at the joint of the burette rim and white cap.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.
Event or Problem Description
It was reported that the bottom of the bd alaris¿ smartsite¿ gravity burette set separated from the chamber of the burrette and leaked.Additionally, 2 other sets also separated from the chamber during use.The following information was provided by the initial reporter: "we have had another incidence of the bottom popping off the chamber of the burette on these sets ¿ one exploded in use and our lead at has bought me another two faulty sets".

• 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 ; 8448235433
• MDR Report Key: 16586848
• Report Number: 9616066-2023-00526
• Device Sequence Number: 1583859
• Product Code: FPA
• UDI-Device Identifier: 10885403244056
• UDI-Public: 10885403244056
• 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): 05/09/2023

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: 10/04/2024
• Device Catalogue Number: 10037032
• Device Lot Number: 21109297
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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