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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON-PRATT; CATHETER, IRRIGATION
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CARDINAL HEALTH 200, LLC JACKSON-PRATT; CATHETER, IRRIGATION Back to Search Results
Model Number JP-2188
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Event Date 06/05/2019
Event Type  Injury  
Event Description
Patient had right breast surgery.Patient went to the physician's office about a week later for a post op follow-up.Dr.Attempted to remove the jp drain from the right breast and the drain broke, leaving a portion in the patient.The patient was brought to (b)(6) to remove the retained portion of the drain.The drain segment was removed and compared with a new drain of the same type to insure that all pieces were removed.Dr.Stated that the drain separated at the connector.Minimal blood loss noted.Product is being sequestered by the risk team.Manufacturer response for jackson pratt channel drain 15fr, (brand not provided), (per site reporter).Vendor notified.
 
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Brand Name
JACKSON-PRATT
Type of Device
CATHETER, IRRIGATION
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key8869441
MDR Text Key153553575
Report Number8869441
Device Sequence Number1
Product Code GBX
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 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberJP-2188
Device Catalogue NumberJP-2188
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2019
Event Location Hospital
Date Report to Manufacturer08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age21900 DA
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