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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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NULL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem Pulmonary Hypertension (4460)
Event Date 01/01/2023
Event Type  malfunction  
Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported the disposable exhibited a leak with male/male luer, 0.2-micron air-eliminating filter, integral anti-siphon valve, and clamp.It was reported some patients exhibited pah symptoms.No further information provided.
 
Manufacturer Narrative
Other text: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.D4: catalog number, udi number, and lot number, and expiration date are unknown; g5: 510k is unknown; h4: device manufacture date is unknown.
 
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Brand Name
CADD EXTENSION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key17350962
MDR Text Key319327164
Report Number3012307300-2023-07249
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2023
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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