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

Catalog Number	10010570
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple batch numbers- 24099223, 24069448, 24069236.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 extension set was leaking.The following information was received by the initial reporter with the following verbatim it was reported by customer that 60¿ extension set w/filter leaking near the filter when in use.
Additional Manufacturer Narrative
It was reported by customer that 60¿ extension set w/filter leaking near the filter when in use.One sample was received for quality evaluation.Visual examination was conducted and the sample received was determined to be different from the reported product.Without further information or the affected sample for investigation- this complaint cannot be verified, and the root cause remains unknown.The three lots of received sample were evaluated for their quality production history: a device history record review for model 10010570 lot number 24099223 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10010570 lot number 24069448 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10010570 lot number 24069236 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS EXTENSION 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: 21210024
• Report Number: 9616066-2025-00052
• Device Sequence Number: 15471528
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: (01)10885403233500(11)240611(17)270611(10)24069236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 03/17/2025

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: 10010570
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown