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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ5307
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/23/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 that minibore bi-fuse pressure 2 iv connector tubing became disconnected.The following information was provided by the initial reporter: it was reported by the customer that the tubing became disconnected.
 
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Brand Name
MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
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
MDR Report Key12055247
Report Number9616066-2021-51384
Device Sequence Number4218523
Product Code FPA
UDI-Device Identifier10885403230608
UDI-Public10885403230608
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K140831
Number of Events Summarized1
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
Report Date (Section B) 06/11/2021
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 Date12/15/2023
Device Catalogue NumberMZ5307
Device Lot Number20126222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2021
Initial Report FDA Received Date06/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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