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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODAN CODAN LOW VOLUME EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

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CODAN CODAN LOW VOLUME EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number BC 568
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Event Description
Hub for extension set was discovered to be broken at the point the clave was attached.(male connection piece broke off into clave) creating an air bubble that the nurse had to remove to avoid it reaching the patient.
 
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Brand Name
CODAN LOW VOLUME EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN
MDR Report Key7086910
MDR Text Key94143323
Report NumberMW5073766
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/01/2017
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 Model NumberBC 568
Device Lot Number73598
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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