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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. RESOLVE LOCKING DRAINAGE CATHETER
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MERIT MEDICAL SYSTEMS INC. RESOLVE LOCKING DRAINAGE CATHETER Back to Search Results
Model Number 00884450009482
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that post-drainage catheter placement within the patient's biliary system, the drainage catheter became damaged at the bend 15 days later and would not continue to drain.The drainage catheter was replaced for this patient.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause was determined to be off-label use.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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Brand Name
RESOLVE LOCKING DRAINAGE CATHETER
Type of Device
DRAINAGE CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
14646 kirby drive
houston TX 77047
MDR Report Key10609999
MDR Text Key209346713
Report Number3010665433-2020-00036
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00884450009482
UDI-Public00884450009482
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number00884450009482
Device Catalogue NumberRLC-8-038/CNB
Device Lot NumberE1620806
Was Device Available for Evaluation? No
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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