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

Catalog Number	82113E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd gravity set was leaking the following information was received by the initial reporter with the following verbatim it was reported by customer that buretrol sets leaking at the bottom of the chamber.
Additional Manufacturer Narrative
H10: it was reported by customer that buretrol sets leaking at the bottom of the chamber.Four samples of product 82113e were submitted for quality evaluation.The samples were primed and leakage was noticed coming from the bottom of the buretrol cylinder.The customer complaint of component damage - leak was confirmed.After the investigation along with the manufacturing and quality operations team, the most potential root cause for the leakage in the bottom cap/burette is a lack of solvent due an incorrect method of solvent application performed by the production personnel by not performing a straight gluing of the burette up to the top of the dispenser guides.A quality alert was to reinforce the correct method to add solvent to the burette, a holding time to the burette engagements during the manufacturing process and additional inspection process.A device history record review for model 82113e lot number 25095819 was performed.There was one quality notification issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS GRAVITY 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24662053
• Report Number: 9616066-2026-00738
• Device Sequence Number: 9289469
• Product Code: FPA
• UDI-Device Identifier: 07613203009591
• UDI-Public: (01)07613203009591(17)280925(10)25095819
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/17/2026

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: Other
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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