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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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CARDINAL HEALTH KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 461243E
Device Problems Break (1069); Leak/Splash (1354); Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2023
Event Type  malfunction  
Event Description
Summary: iris ng tubes continue to break and are a defective product.The patients continue to experience malfunctions, leaks, breaks, and defects in this cheaply made piece of medical equipment.On the day of this incident, when attempting to administer medications the plastic end of the ng tube fell apart in this rn's hand, without pressure or without fully connecting a syringe to any port.Product is labeled as follows: manufacturer: coviden, feeding tube with iris technology, 12fr ch(4.0mm) x43" (109cm), ref (b)(4).
 
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Brand Name
KANGAROO
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
CARDINAL HEALTH
444 mcdonnell blvd.
hazelwood MO 63042
MDR Report Key16610432
MDR Text Key312161262
Report Number16610432
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number461243E
Device Catalogue Number461243E
Device Lot Number1243080122
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/21/2023
Event Location Hospital
Date Report to Manufacturer03/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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