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

Catalog Number	42519E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 the bd alaris¿ smartsite¿ gravity set had a loose connection.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.1 the connections are not tight.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ gravity set had a loose connection.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.1 the connections are not tight.".
Additional Manufacturer Narrative
H6: investigation summary: three samples were submitted for quality investigation.One of the samples was received without a drip chamber, however, the customer did not indicate that this was a failure and it could not be determined if the drip chamber separated from the assembly or if it was cut away from the assembly.The customer complaint of connection issue was not verified by investigation of the samples.The connections for each infusion set were checked to make sure they were hand tight.All connections and caps were verified hand tight.The sets were then clamped below the drip chamber location, and pressurized with air.While pressurized the set was submerged in water and checked to see if the connections remained sealed.There were no indications of bubbles coming from the assemblies and therefore the reported connection issues could not be verified.No other issues were identified on the samples.A device history record review for model 42519e lot number 22109332 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the reported connection issues could not be determined because the failure could not be replicated.

• 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: 16317632
• Report Number: 9616066-2023-00142
• Device Sequence Number: 7992802
• Product Code: FPA
• UDI-Device Identifier: 07613203010870
• UDI-Public: 07613203010870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 03/03/2023

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: 10/18/2025
• Device Catalogue Number: 42519E
• Device Lot Number: 22109332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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