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	01/09/2023
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 that the bottom of the bd alaris¿ smartsite¿ gravity burette set separated while being filled and leaked out antibiotics.The following information was provided by the initial reporter: "bottom of the burettes came off when filled.One nurse lost a dose of antibiotics.Only saline was lost in other instances.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-feb-2023.H6: investigation summary: two 10037032 samples from lot 21109297 were received in opened packaging for investigation; residual fluid was present in both devices.The feedback provided by the customer suggests the base of the burette had separated when filled with medication.A visual inspection of the returned samples confirms the customer's experience; as the devices were returned separated.A close inspection of the drip chamber base and white cap reveals minimal residual solvent is visible at the affected joint.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 while being filled and leaked out antibiotics.The following information was provided by the initial reporter: "bottom of the burettes came off when filled.One nurse lost a dose of antibiotics.Only saline was lost in other instances.".

• 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: 16261162
• Report Number: 9616066-2023-00105
• Device Sequence Number: 6728729
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: Health Professional
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 04/26/2023
• 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