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 Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd alaris smartsite gravity burette sets experienced component separation.The following information was provided by the initial reporter: on all occasions the line had not yet been connected to the patient.The nurses were showered with antibiotic from the burette when it dropped to the floor and nacl from the iv fluid bag.They had to open new giving sets and are now taping the white disk to the burette to prevent it from happening again.
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: 10-oct-2022 investigation summary one 10037032 sample from lot 21109297 was received in opened packaging for investigation residual fluid was present in the device.A visual inspection of the returned sample confirms the customer's experience, as the white cap was received separated from the rest of the burette set.A close inspection of the rim of the burette and the inside of the burette cap did not identify the presence of any 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 top of 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 3 bd alaris smartsite gravity burette sets experienced component separation.The following information was provided by the initial reporter: on all occasions the line had not yet been connected to the patient.The nurses were showered with antibiotic from the burette when it dropped to the floor and nacl from the iv fluid bag.They had to open new giving sets and are now taping the white disk to the burette to prevent it from happening again.

• 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: 15601051
• Report Number: 9616066-2022-01537
• Device Sequence Number: 11328664
• 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): 10/25/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/09/2022
• 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