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

Catalog Number	47233E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite gravity set was damaged.The following information was received by the initial reporter with the following verbatim: customer had a product issue with 47233e.This is what i received from our reporter: ¿iv gravity tubing that pieces were popping off; the spike piece and where the port attached to further tubing¿.I have three in my office.
Additional Manufacturer Narrative
Dhr no product or photo was returned by the customer.The customer complaint of pieces popping off gravity sets could not be verified due to the product not being returned for failure investigation.Device history record review for model 47233e lot number 23079278 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Additional reply affecting ar code customer reply: 1.Did the event leads to any leak? none reported.2.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.Did not get to the patient.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18427575
• Report Number: 9616066-2023-02463
• Device Sequence Number: 18075248
• Product Code: FPA
• UDI-Device Identifier: 50885403235441
• UDI-Public: (01)50885403235441
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 07/29/2026
• Device Catalogue Number: 47233E
• Device Lot Number: 23079278
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown