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

Catalog Number	10012564
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd smartsite gravity burette set experienced component separation and leakage.The following information was provided by the initial reporter: the bottom blows off when the nurse squeezes the iv fluid into it.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: the customer reported the gravity burette set blows off when pressure is applied, and returned 6 separated samples.All 6 of the samples were separated at the bottom of the burette, and the complaint is verified.The samples all had the same failure, and the same root cause of insufficient solvent applied during assembly.Manufacturing is aware of the failure and this root cause.A device history record review for model 10012564 lot number 22039290 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : h.10.
Event or Problem Description
It was reported that 3 bd smartsite gravity burette set experienced component separation and leakage.The following information was provided by the initial reporter: the bottom blows off when the nurse squeezes the iv fluid into it.

• Brand Name: BD 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: 15080739
• Report Number: 9616066-2022-00932
• Device Sequence Number: 17346911
• Product Code: FPA
• UDI-Device Identifier: 10885403233746
• UDI-Public: 10885403233746
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: Health Professional
• Device Expiration Date: 03/24/2025
• Device Catalogue Number: 10012564
• Device Lot Number: 22039290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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