MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE ADD-ON BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013365
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd smartsite add-on bag access device was occluded.The following information was received by the initial reporter with the verbatim: smart-site bd spike not allowing flush to be pushed into medication bag.Staff needed to switch bag of saline to flush medication.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that smart-site bd spike not allowing flush to be pushed into medication bag.No product or photo was returned by the customer.The customer complaint of flow issue - fluid blockage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 10013365 lot number 22115487 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.Material #: 10013365 batch #: (10)22115487.It was reported by customer that smart-site bd spike not allowing flush to be pushed into medication bag.Staff needed to switch bag of saline to flush medication.Verbatim: rcc received a complaint via email.Email(s) attached.Smart-site bd spike not allowing flush to be pushed into medication bag.Staff needed to switch bag of saline to flush medication.Photos included and supplies kept to view.

• Brand Name: BD SMARTSITE ADD-ON BAG ACCESS DEVICE
• 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: 18083375
• Report Number: 9616066-2023-02156
• Device Sequence Number: 18110117
• Product Code: FPA
• UDI-Device Identifier: 27613203013912
• UDI-Public: (01)27613203013912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: 11/23/2025
• Device Catalogue Number: 10013365
• Device Lot Number: 22115487
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown