MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER; INTRAVASCULAR ADMINISTRATION SET

Model Number	20350ET
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported there were 2 occurrences of opening bd smartsite¿ extension set, low sorbing, 0.2 micron filter that the end cap was missing.There was no report of patient impact.The following information was provided by the initial reporter: 2 of the in-line filter opened today have no white cap attached at the end of the line.Picture shown is one of them, we have a total of 2.Name of the in-line filter is bd low sorbing extension set (0.2 micron low protein binding filter), ref (b)(4).
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 24-jul-2023.H.6.Investigation summary: 2 unused samples received from customer.It was reported by the customer that 2 of the in-line filter sets have no white cap attached at the end of the line.Further visual inspection of the extension set shows that the white cap was missing from the luer component and the complaint has been verified.A notification was sent to the manufacturer.After the manufacturer's investigation, it was determined that the condition of misassembly (missing component) has a root cause traced to the assembly line working outside of proper sequence at the plant.A quality alert has since been created and the responsible operators have been reinstructed on proper procedure to ensure this failure no longer occurs.A device history record review for model 20350et and lot number 21059703 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported there were 2 occurrences of opening bd smartsite¿ extension set, low sorbing, 0.2 micron filter that the end cap was missing.There was no report of patient impact.The following information was provided by the initial reporter: 2 of the in-line filter opened today have no white cap attached at the end of the line.Picture shown is one of them, we have a total of 2.Name of the in-line filter is bd low sorbing extension set (0.2 micron low protein binding filter), ref (b)(4).

• Brand Name: BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER
• 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 ; 8448235433
• MDR Report Key: 17095862
• Report Number: 9616066-2023-01140
• Device Sequence Number: 1988733
• Product Code: FPA
• UDI-Device Identifier: 50885403229754
• UDI-Public: (01)50885403229754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 09/28/2023

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 Model Number: 20350ET
• Device Catalogue Number: 20350ET
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/02/2023
• 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