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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK MEDICAL; RING DRAINAGE CATHETER NEEDLESET
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COOK INCORPORATED COOK MEDICAL; RING DRAINAGE CATHETER NEEDLESET Back to Search Results
Model Number REF G03388
Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  Injury  
Event Description
Transvaginal drain placement requested for pelvic abscess.Tvsono guided needle approach with sheathed needle performed.Difficult access due to height aka cranial level of collection and posterior anatomic location.First attempt with needle access failed as sheath popped out of the collection.Needle reinserted into sheath and access reattempted.Failure to gain access prompted exchange for the sheathed needle for a hard 18g trocar needle which was used to gain access and wire access allowed placement of transvaginal pelvic drain.Drain fell out on the inpatient floor the next day prompting of the pt and foreign body believed to be plastic piece of needle sheath identified.
 
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Brand Name
COOK MEDICAL
Type of Device
RING DRAINAGE CATHETER NEEDLESET
Manufacturer (Section D)
COOK INCORPORATED
bloomington IN 47404
MDR Report Key7209043
MDR Text Key97976041
Report NumberMW5074692
Device Sequence Number1
Product Code DWO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberREF G03388
Device Catalogue NumberDLPN-40-25-RING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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
Patient Outcome(s) Required Intervention;
Patient Age48 YR
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