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

Catalog Number	10053857
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 of the bd gravity administration set disconnecting below the drip chamber.The following information was provided by the initial reporter: fasc has had 3 reports of bd smartsite gravity sets ref.(b)(4) disconnecting below the drip chamber.
Event or Problem Description
It was reported that 2 of the bd gravity administration set disconnecting below the drip chamber.The following information was provided by the initial reporter: fasc has had 3 reports of bd smartsite gravity sets ref.100053857 disconnecting below the drip chamber.
Additional Manufacturer Narrative
H6: investigation summary no photo or sample was received for the customer's complaint of separation.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD GRAVITY ADMINISTRATION 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: 16056808
• Report Number: 9616066-2022-02071
• Device Sequence Number: 5306786
• Product Code: FPA
• UDI-Device Identifier: 10885403234125
• UDI-Public: 10885403234125
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/30/2023

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: 10053857
• Device Lot Number: UNKNOWN
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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