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	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris smartsite gravity set was clogged.The following information was provided by the initial reporter: they were double checking the valves in the giving set and found one of the valves is back to front hence there is no free flow of infusion fluid.
Additional Manufacturer Narrative
Investigation summary.One 42290e sample was received for investigation without packaging, and the lot number was indicated as 21056486.The product was received connected to a baxter iv bag with sodium chloride solution in the line.The sample was subjected to functional testing by subjecting it to a flush through of fluid, the customer's experience was confirmed as an occlusion was observed.A visual inspection confirmed the customer's experience as the set was assembled with two back check valves (bcv) and one of the two bcv was identified to have been assembled back to front.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 two bcvs were inadvertently assembled onto the tubing.A review of the production records for lot 21056486 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 42290e product over the past 12 months.
Event or Problem Description
Family.4836601.4888064 - pr# (b)(4) clogged/blocked/occluded.Division / project: business process / mdr created: 2022-04-04 10:44 am.Save.Save & exit.Cancel.New.Copy.Child.Check spelling.Workflow.Pending successful ack3submission acceptedin state for 15 days.Activity type.Enter your selection here.Date scheduled.Calendar.Now.Person responsible.Search.Date performed.Calendar.Now.Show all fields.Mdr ownership.Patient information (a).Adverse event or prod prob (b).Suspect products (c).Suspect medical device (d).Med device reprocess info (d).Initial reporter (e).User facility / importer (f).All manufacturers (g).Device manufacturers only (h).Approvals and acknowledgements.Supporting documents and notes.Hidden fields.Adverse type.Product problem.Date of event.2022-03-28.Event attributed to.If you select other - please explain in field "other details".Death? no.Date of death.Other details.If event attributed to has been populated as other enter the details here - otherwise enter 'n/a" here.Na.Describe event or problem maximize.It was reported that the bd alaris smartsite gravity set was clogged.The following information was provided by the initial reporter: they were double checking the valves in the giving set and found one of the valves is back to front hence there is no free flow of infusion fluid.Relevant tests/laboratory data maximize.None reported.Other relevant history maximize.

• 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: 14146668
• Report Number: 9616066-2022-00424
• Device Sequence Number: 15025714
• 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): 04/28/2022

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 Model Number: 42290E
• Device Catalogue Number: 42290E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/23/2022
• 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