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

Model Number	42290E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported 2 bd alaris smartsite gravity sets had blockage issues during priming.The following information was provided by the initial reporter: "the sets were observed to not be flowing during priming".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported 2 bd alaris smartsite gravity sets had blockage issues during priming.The following information was provided by the initial reporter: "the sets were observed to not be flowing during priming".
Additional Manufacturer Narrative
H.6.Investigation: four 42290e samples were received in opened packaging from lot 21079143; residual fluid was present in all of the received samples.The samples were connected to a fluid bag from stock and fluid was allowed to flow through under gravity in order to replicate the customer's experience; no fluid was able to pass beyond the back check valve in three of the four returned samples.A visual inspection identified that the back check valve had been assembled upside-down in each of the three affected samples.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the customer's experience is likely to have occurred as a result of human error during the assembly process, whereby the back check valve was inadvertently assembled upside-down on the infusion set.A review of the production records for lot 21079143 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• Brand Name: BD ALARIS SMARTSITE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14286043
• Report Number: 9616066-2022-00521
• Device Sequence Number: 14995781
• Product Code: FPA
• UDI-Device Identifier: 37613203010949
• UDI-Public: 37613203010949
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 07/20/2024
• Device Model Number: 42290E
• Device Catalogue Number: 42290E
• Device Lot Number: 21079143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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