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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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NULL CADD EXTENSION SET; 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  
Event Description
It was reported that the customer received a spike in complaints from patients related to leaky cadd extension set with male/male luer, 0.2-micron air-eliminating filter, integral anti-siphon valve, and clamp.Customer asked if there was a known defect with this tubing.Patients were asked to return their leaky extension sets to them for further evaluation.Received from accredo a report with malfunction from (b)(6) 2023, where 67 patients were affected.About injuries no major issues were reported, some patients mentioned exhibiting pulmonary arterial hypertension symptoms.
 
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.
 
Manufacturer Narrative
Other, 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.
 
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Brand Name
CADD EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key17351394
MDR Text Key319859390
Report Number3012307300-2023-07272
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 11/17/2023
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 Received10/26/2023
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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