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

Catalog Number	82113E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
End cap is coming off the burette.No patient harm.
Additional Manufacturer Narrative
The customer reported the cap is coming off the burette, and returned 6 samples: one opened, and 5 sealed.The samples are all of material 82113e, lot 25095819.Of the 6 samples, 2 confirmed the reported of cap coming off, and separating from the burette.This consisted of the one opened set, and one of the unopened.In addition, both sets separated at the cap and also on the spike side, leaving an open burette cylinder with no sides.The other 4 unopened sets showed no defects.The burettes that separated were observed under a microscope, and insufficient solvent was found.A device history record review was performed.There was a quality notification issued for the failure mode reported by the customer during the production build of this set - related to leak from the top of the burette.The manufacturing plant found the root cause for the separation to be related to incorrect solvent application by the assembler.The quality notification issued an investigation into the failure on nov.14th, 2025.Under this, a quality notification was displayed to reinforce the correct solvent application method of the burette with solvent dispensers.An engineering evaluation was put under process to look into the holding time for after the solvent is applied to the burette.

• Brand Name: V/NV BURETTE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24184192
• Report Number: 9616066-2026-00114
• Device Sequence Number: 9569554
• Product Code: FPA
• UDI-Device Identifier: 07613203009591
• UDI-Public: (01)07613203009591(17)280925(10)25095819
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 Catalogue Number: 82113E
• Device Lot Number: 25095819
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown