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

Catalog Number	82113E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
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 the bd alaris smartsite add-on burette set separated.The following information was provided by the initial reporter: the spike/closure piercing device, which connects to the iv bag, has been detaching.One packet arrived with the spike already separated from the tubing, and others have become disconnected while pitocin was infusing.Additional information received from the customer: what was the impact to the patient? on (b)(6) 2025 pitocin bag and tubings changed immediately after the incident.Incident interrupted continuous administration of medication.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details no.
Additional Manufacturer Narrative
It was reported by the customer that the spike/closure piercing device, which connects to the iv bag, has been detaching.One packet arrived with the spike already separated from the tubing, and others have become disconnected while pitocin was infusing.One photo was received for quality evaluation.Inspection of the photo indicates that the spike separated from the infusion set tubing.The customer complaint of separation was confirmed.The investigation was forwarded to manufacturing for a possible root cause analysis.Due to a physical sample not being provided, an exact root cause could not be determined.A possible root cause could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.No actions were taken because the product of this product was moved to a new location after this production lot had already been produced.The current work constructions at the new manufacturing site have the controls to assure the proper assembly between components.A device history record review for model 82113e lot number 25019315 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE ADD-ON BURETTE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22989625
• Report Number: 9616066-2025-02686
• Device Sequence Number: 21081910
• Product Code: FPA
• UDI-Device Identifier: 07613203009591
• UDI-Public: (01)07613203009591(17)280114(10)25019315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 25019315
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/07/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown