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

Catalog Number	10794983
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd alaris extension set occluded.The following information was provided by the initial reporter with the verbatim: when hanging new iv fluid and lines, i was unable to flush the bifuse from either port.I removed the nads and still unable to flush.Psr (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation.No product or photo was returned by the customer.It was reported by customer that when hanging new iv fluid and lines, they were unable to flush the bifuse from either port.The customer complaint 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 10794983, lot number 22119155 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18nov2022.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.

• Brand Name: BD ALARIS EXTENSION 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795036
• Report Number: 9616066-2023-01928
• Device Sequence Number: 20520367
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: (01)50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: 10794983
• Device Lot Number: 22119155
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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