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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC
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BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Model Number 30935
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date as the exact event date was not reported.
 
Event or Problem Description
It was reported that the hub detached.A 12 flexima apdl catheter drainage was used.It was noted that the hub detached as the white cuff pulled away from the blue shaft.No patient complications were reported.
 
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Brand Name
FLEXIMA APDL
Common Device Name
TUBE, DRAINAGE, SUPRAPUBIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8748487
Report Number2134265-2019-07592
Device Sequence Number13992030
Product Code FFA
UDI-Device Identifier08714729323143
UDI-Public08714729323143
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K944290
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/09/2022
Device Model Number30935
Device Catalogue Number30935
Device Lot Number0023626649
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2019
Initial Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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