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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ9265
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a complaint of a broken connector was received from the customer. One sample was returned for investigation. Through visual inspection, the customer complaint was confirmed. Male luer was not attached to the set. The luer was not returned with the rest of the set. A device history record review for model mz9265 lot number 21075983 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 14jul2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A definitive root cause could not be determined as the male luer was not returned with the sample. A potential root cause for the defect is an insufficient amount of solvent being added to the connection site of the tubing and the luer. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: one sample was returned for investigation. Through visual inspection, the customer complaint was confirmed. Male luer was not attached to the set. The customer did not return the luer. A definitive root cause could not be determined as the male luer was not returned with the sample. A potential root cause for the defect is an insufficient amount of solvent being added to the connection site of the tubing and the luer.
 
Event Description
It was reported that the bd microbore bi-fuse extension set, 2 iv co experienced device damage while still considered operable. The following information was provided by the initial reporter: the iv bifuse piece that is usually connected to the t-connector was broken and unable to be reattached.
 
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Brand NameBD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12862610
MDR Text Key285826205
Report Number9616066-2021-52477
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20885403240772
UDI-Public20885403240772
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMZ9265
Device Lot Number21075983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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