MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD PRIMARY GRAVITY IV ADMINISTRATION SETS - IV GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	42103E-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter phone #: unknown.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
¿it was reported that the bd primary gravity iv administration sets - iv gravity set experienced separation.The following information was provided by the initial reporter: tubing came apart at distal port.
Event or Problem Description
¿it was reported that the bd primary gravity iv administration sets - iv gravity set experienced separation.The following information was provided by the initial reporter: tubing came apart at distal port.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 21109114, d.4.Medical device expiration date: 20-oct-2024, h.4.Device manufacture date: 20-oct-2021.H.6.Investigation summary: a sample was received and tested by our quality team.The set was separated upon receipt and the customer's complaint has been verified.After visual analyses under microscope, the set was lacking solvent necessary to connect tubing to the lower smart site-this is the root cause.The manufacturing plant has been made aware of this issue.A device history record review for model 42103e-07 lot number 21109114 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20oct2021.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h.10.

• Brand Name: BD PRIMARY GRAVITY IV ADMINISTRATION SETS - IV 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: 14465822
• Report Number: 9616066-2022-00650
• Device Sequence Number: 4504681
• Product Code: FPA
• UDI-Device Identifier: 50885403225848
• UDI-Public: 50885403225848
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/04/2022

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: 10/20/2024
• Device Model Number: 42103E-07
• Device Catalogue Number: 42103E-07
• Device Lot Number: 21109114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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