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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II 8F INTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB

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OSCOR INC. SAFESHEATH II 8F INTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB Back to Search Results
Model Number SS8
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
It was reported that a safesheath introducer broke right at the hub instead of peeling away as designed, a cutter was used to remove the introducer out of the patient - no issue for patient, but was difficult to get out.
 
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Brand NameSAFESHEATH II 8F
Type of DeviceINTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor, FL 34683-1816
7279372511
MDR Report Key12226526
MDR Text Key263480232
Report Number1035166-2021-00074
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00802526532474
UDI-Public00802526532474
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS8
Device Catalogue NumberSS8
Device Lot NumberDP12030
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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