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

Catalog Number	41173E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.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 bd alaris¿ smartsite¿ gravity set the roll clamp was discovered to be missing.The following information was provided by the initial reporter: health professional called in to report that the product is supposed to come with roll clamp but did not have one in the package.
Event or Problem Description
It was reported that prior to use with bd alaris¿ smartsite¿ gravity set the roll clamp was discovered to be missing.The following information was provided by the initial reporter: health professional called in to report that the product is supposed to come with roll clamp but did not have one in the package.
Additional Manufacturer Narrative
H6: investigation summary a complaint of the set missing a roller clamp was received from the customer.A photo was received for investigation.It was observed that the roller clamp was not assembled onto the set.The customer complaint was confirmed.A device history record review for model 41173e lot number 22069340 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being received, a root cause could not be determined.H3 other text : see h10.

• 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 ; 8448235433
• MDR Report Key: 17131247
• Report Number: 9616066-2023-01180
• Device Sequence Number: 6458031
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 07613203020893
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 06/16/2025
• Device Catalogue Number: 41173E
• Device Lot Number: 22069340
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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