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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL MEDEX STOPCOCK; STOPCOCK, I.V. SET
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NULL MEDEX STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number B19311LG2
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Photos were returned for investigation.Upon visual inspection, it was found that the complained issue could be duplicated as it was over tightened.The problem source is unknown.Dhr review was done, no issues related to the original complaint were found.
 
Event Description
It was reported that there was a cracked observed on the clear housing of the yellow stopcock.No additional information.
 
Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-09754.The report was submitted in error.
 
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Brand Name
MEDEX STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section G)
NULL
MDR Report Key14517179
MDR Text Key292824111
Report Number3012307300-2022-09754
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/08/2023
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
Device Operator Health Professional
Device Catalogue NumberB19311LG2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/02/2022
Initial Date FDA Received05/26/2022
Supplement Dates Manufacturer Received05/05/2023
Supplement Dates FDA Received05/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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