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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRESSURE RATED EXT SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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PRESSURE RATED EXT SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ5303
Device Problems Backflow (1064); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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.
 
Event Description
It was reported that blood back-flowed through the pressure rated ext set, iv connector after the contrast radiography and ct exam, leaking around the pivc.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, blood flowed backwards from the site of connection to the iv route." "the customer performed contrast radiography and ct.After the test is done, the customer found back flow of blood for the used medical device and leakage around pivc was found.".
 
Manufacturer Narrative
H6: investigation summary : one mz5303 sample was received without packaging for investigation.The customer feedback indicates that the complaint sample was from lot 20096065.The sample was received connected to an unknown extension set; blood was present in the samples.A visual inspection did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Pressure testing did not identify any leakage from any point of the line throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20096065 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.Please note that maxzero valves are not back check valves and are not designed to prevent back flow when connected to another infusion set.Furthermore as stated in the directions for use of the maxzero valve "flush the maxzero after each use with normal saline or in accordance with facility protocol.Failure to properly prime the device can result in reflux." a review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the mz5303 product over the past 12 months.H3 other text : see h10.
 
Event Description
It was reported that blood back-flowed through the pressure rated ext set, iv connector after the contrast radiography and ct exam, leaking around the pivc.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, blood flowed backwards from the site of connection to the iv route." "the customer performed contrast radiography and ct.After the test is done, the customer found back flow of blood for the used medical device and leakage around pivc was found.".
 
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Brand Name
PRESSURE RATED EXT SET, IV CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12367713
MDR Text Key268218209
Report Number9616066-2021-51893
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 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/15/2023
Device Model NumberMZ5303
Device Catalogue NumberMZ5303
Device Lot Number20096065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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