MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	30935
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.The catheter returned has the hub detached (the heat shrink was received properly attached to the hub); moreover, the flare of the extrusion was found formed, it is evidence that the manufacturing process was properly performed.The catheter returned with detached hub.The catheter was also cut at 12cm from the flare end.The rest of the catheter was not returned for analysis.
Event or Problem Description
Reportable based on device analysis completed on 12sep2019.A flexima apdl catheter drainage was received with no reported issues.However, analysis revealed hub detached.

• 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 Key: 9152291
• Report Number: 2134265-2019-11948
• Device Sequence Number: 2782643
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: 08714729323143
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• 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): 10/03/2019

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 Date: 05/15/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023803685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1