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

Catalog Number	72215N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
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 alaris secondary set was separated.The following information was received by the initial reporter with the following verbatim.It was reported by customer that the hub of the primary tubing does not connect well to the thread on the secondary tubing.The connection comes apart and causes medication and blood to go to the floor.
Additional Manufacturer Narrative
Sample was returned under (b)(4).One sample was received for quality evaluation.Visual examination was conducted on the sample, no damages or abnormalities identified.The sample was then primed and attached to a sample secondary bd infusion set and a sample bd extension set at the distal end of the infusion set.A simulated infusion was conducted at a rate of 125 ml/hr to determine if there was and air-in-line, occlusion or leakage issues.There were no issues identified.All additional y-site smartsites were tested by connecting a syringe to the luer port and conducting a fluid push to determine if the threaded connection leaks.No issues were identified.The customer complaint of connection issues could not be confirmed.A root cause for the reported failure was not determined because the failure was not replicated.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information provided.

• Brand Name: BD ALARIS SECONDARY 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: 21554711
• Report Number: 9616066-2025-00467
• Device Sequence Number: 20890038
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: (01)10885403235467(11)240913(17)270913(10)24099386
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 04/30/2025

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: 72215N
• Device Lot Number: 24099386
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown