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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PRESSURE RATED EXT SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PRESSURE RATED EXT SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ5303
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the pressure rated ext set, iv connector had a loose connection to the terumo iv line.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported about loose connection between mz5303 and terumo's iv line.".
 
Manufacturer Narrative
The following fields were updated due to corrected information: d.10.Device available for eval?: no.H.6.Investigation: a mz5303 sample was not available for investigation of this feedback; however the customer indicates that the connection between the maxzero and the male luer of a terumo product was not secure.The connecting terumo product in use at the time of the customer's experience was not returned to assist the investigation.The customer provided photographs of the affected sample; analysis of the photographs confirmed the affected lot to be 20045220.A review of the production records for lot 20045220 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.
 
Event Description
It was reported that the pressure rated ext set, iv connector had a loose connection to the terumo iv line.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported about loose connection between mz5303 and terumo's iv line.".
 
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Brand Name
PRESSURE RATED EXT SET, IV CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX  22244
MDR Report Key11102925
MDR Text Key224796309
Report Number9616066-2020-20701
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403230569
UDI-Public50885403230569
Combination Product (y/n)N
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/16/2023
Device Model NumberMZ5303
Device Catalogue NumberMZ5303
Device Lot Number20045220
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/09/2020
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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