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

Model Number	10012564
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd smartsite gravity burette set the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: when fluid placed in buretrol bottom is popping off.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-jun-2023.Investigation summary: a complaint of burette bottom popping off was received from the customer.Twenty unused samples were received for investigation.Through visual inspection inside the packaging, no defects or damages were observed.The packages were then opened, and the burettes were lightly pulled to see if the burette would separate easily.Five burettes separated from the lower part of the set.The customer complaint was confirmed.A device history record review for model 10012564 lot number 22039290 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was performed.After investigation, the potential root cause for separation between burette and cap could be related to lack of solvent by failure in the crc solvent dispenser.This failure mode was addressed under a quality notification.The corrective action taken was improvement of crc solvent dispensers additionally, a quality alert was generated to reinforce the escalation of failure in solvent dispensers.A work order will be generated to verify the good condition of crc dispensers.
Event or Problem Description
It was reported while using bd smartsite gravity burette set the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: when fluid placed in buretrol bottom is popping off.

• 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: 17148700
• Report Number: 9616066-2023-01199
• Device Sequence Number: 5818164
• Product Code: FPA
• UDI-Device Identifier: 50885403233744
• UDI-Public: (01)50885403233744
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/29/2023

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 Model Number: 10012564
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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