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

Catalog Number	20019E
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set y-site detached and caused iv fluid to leak out during use.The following information was provided by the initial reporter: "y site became disconnected despite not being touched (and site parafilm still intact) and iv fluids leaked out of y site.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 06-jan-2023.Investigation summary: 2 samples were received and tested by our quality team with the complaint of separation.The sets were infused with saline from all ports and when correctly tightened, there was no leakages or separations to be reported.The complaint cannot be verified and there is no root cause to be found.The manufacturer has been notified of this complaint.A device history record review was performed and there were no relevant production issues or quality notifications with the mat # 20019e sets of the following lots: 22085888, and 22085889.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set y-site detached and caused iv fluid to leak out during use.The following information was provided by the initial reporter: "y site became disconnected despite not being touched (and site parafilm still intact) and iv fluids leaked out of y site".

• Brand Name: BD ALARIS¿ SMARTSITE¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16043559
• Report Number: 9616066-2022-02066
• Device Sequence Number: 5237682
• Product Code: FPA
• UDI-Device Identifier: 07613203012010
• UDI-Public: 07613203012010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 20019E
• Device Lot Number: UNKNOWN
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown