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

Catalog Number	10012564
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd smartsite¿ gravity burette set the connection was separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we have had multiple reports of buretrols falling about from our anesthesia department.I have not received the ref but i do have the lot# if you are able to look that up.We were asked to pull all product with that lot number, but waiting to hear back on if that is the only lot we have on hand.The iv came apart within 5 minutes or less once it was connected to the patient.No medication infused.No patient harm.Was there any leakage found during the incident? i¿m not sure what the ask is.The buretrol fell apart so yes there was leaking.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd smartsite¿ gravity burette set the connection was separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we have had multiple reports of buretrols falling about from our anesthesia department.I have not received the ref but i do have the lot# if you are able to look that up.We were asked to pull all product with that lot number, but waiting to hear back on if that is the only lot we have on hand.The iv came apart within 5 minutes or less once it was connected to the patient.No medication infused.No patient harm.Was there any leakage found during the incident? i¿m not sure what the ask is.The buretrol fell apart so yes there was leaking.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 05-jun-2023 h.6.Investigation summary: 6 unused samples and 1 photo sample were received by the customer.It was reported by the customer that they had multiple reports of burettes falling apart was verified by photo sample.The root cause is unable to be identified without the physical sample for investigation.Functional testing was performed on 6 unused samples, and they were not showing any separation issue of burette from the set.The set was examined for other defects and abnormalities.A kink in tubing was found right below the drip chamber in 2 of the unopened samples of the set.Tubing was kinked and did not allow the flow from the set.A device history record review for model 10012564 and lot number 22039290 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no actual defective sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SMARTSITE¿ GRAVITY BURETTE 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: 16959269
• Report Number: 9616066-2023-00951
• Device Sequence Number: 17505966
• Product Code: FPA
• UDI-Device Identifier: 10885403233746
• UDI-Public: (01)10885403233746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• 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): 09/19/2023

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: 03/24/2025
• Device Catalogue Number: 10012564
• Device Lot Number: 22039290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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