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

Catalog Number	42511E
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of stopcock handle being assembled incorrectly was received from the customer.A photo of the assembly drawing was returned for investigation.A device history record review for model 42511e lot number 22109098 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 05oct2022.There was a quality notification issued for the failure mode reported by the customer during the production build of this set.Due to the defect not being able to be seen in the photo, the failure could not be confirmed, and a root cause could not be determined.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 h.10.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ gravity set had a stopcock handle that was assembled 180° in opposite direction.The following information was provided by the initial reporter: it was reported by the customer that stopcock handle was assembled 180° in opposite direction.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17374704
• Report Number: 9616066-2023-01504
• Device Sequence Number: 15205882
• Product Code: FPA
• UDI-Device Identifier: 10885403235412
• UDI-Public: 10885403235412
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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
• Report Date (Section B): 07/05/2023

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 Catalogue Number: 42511E
• Device Lot Number: 22109098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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