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

Model Number	82113
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that 4 bd alaris add-on burette set experienced leakage.The following information was provided by the initial reporter: we had several more leaking butestrol discovered over the weekend with this same lot #.One nurse noted that there appears to be an issue with the adhesive on the bottom of the tubing.
Additional Manufacturer Narrative
H6: investigation summary: the customer reported multiple occurrences of leakage from the bottom of the buretrol on 82113.The customer provided no physical sample with this complaint, but did provide a picture of the solvent issue at the bottom, and the complaint is verified.A device history record review for model 82113 lot number 21119767 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23nov2021.There was a quality notification issued for the failure mode when the leak test was not passed, and manufacturing began working on the issue.Manufacturing found the root cause to be partial gumming on the ends of the solvent dispenser.H3 other text : see h10.
Event or Problem Description
It was reported that 4 bd alaris add-on burette set experienced leakage.The following information was provided by the initial reporter: we had several more leaking buretrols discovered over the weekend with this same lot #.One nurse noted that there appears to be an issue with the adhesive on the bottom of the tubing.

• Brand Name: BD ALARIS ADD-ON 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: 14835927
• Report Number: 9616066-2022-00770
• Device Sequence Number: 4832593
• Product Code: FPA
• UDI-Device Identifier: 37613203009622
• UDI-Public: 37613203009622
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: 11/18/2024
• Device Model Number: 82113
• Device Catalogue Number: 82113
• Device Lot Number: 21119767
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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