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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55112
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Event Description
It was reported that the box was mislabeled.Two ekosonic catheters were selected for use in a procedure.The reference numbers on the on the external packaging were different than the number on the labeling inside the package.
 
Manufacturer Narrative
D4 - lot number: corrected to 8035040742.D4 - expiration date: corrected to 07/18/2024.D4 - serial number: corrected to (b)(6).
 
Event Description
It was reported that the box was mislabeled.Two ekosonic catheters were selected for use in a procedure.The reference numbers on the on the external packaging were different that the number on the labeling inside the package.
 
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Brand Name
EKOSONIC KIT 106CM 12CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12702901
MDR Text Key278525520
Report Number2134265-2021-13284
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public00858593006134
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-55112
Device Catalogue Number500-55112
Device Lot Number8035040742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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