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

Model Number	72213N
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 that prior to use with 2 bd alaris¿ secondary set the device was discovered to have a piece missing while in the package.The following information was provided by the initial reporter: it was reported by customer that bd secondary set found broken in package.What component of the tubing set was damaged/broken/missing? the connecting piece is missing.Incomplete manufacturing?.
Event or Problem Description
It was reported that prior to use with 2 bd alaris¿ secondary set the device was discovered to have a piece missing while in the package.The following information was provided by the initial reporter: it was reported by customer that bd secondary set found broken in package.What component of the tubing set was damaged/broken/missing? the connecting piece is missing.Incomplete manufacturing?.
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: 11-jul-2023.H.6.Investigation summary: one sample was received for quality investigation.The customer complaint of component damage/no leak was verified by inspection.Evaluation of the submitted sample shows that the distal end luer connector is missing.Further inspection of the sample under magnification shows that there is sufficient solvent at the distal end of the tubing for the luer connection, however, the customer had reported that the secondary set was already missing the luer inside the packaging.A device history record review for model 72213n lot number 23019070 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation at the manufacturing facility determined that the root cause for the issue, seen in the sample submitted, is that formation of gaps would occur during the joining of components by the assembler.A quality alert was created on 13sep2023 and communicated to production personnel to inform of this failure mode and reinforce the correct operation to avoid misassembly of the set.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.

• Brand Name: BD ALARIS¿ SECONDARY 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 ; 8448235433
• MDR Report Key: 17276177
• Report Number: 9616066-2023-01371
• Device Sequence Number: 17436580
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: (01)07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 09/20/2023

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 Expiration Date: 01/05/2026
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: 23019070
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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