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

Model Number	30935
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated as event date was not reported.
Event or Problem Description
It was reported that the packaging seal was compromised.An 8fr flexima apdl drainage catheter was received with the package opened along its length.The device was not useable.There were no patient complications reported.
Event or Problem Description
It was reported that the packaging seal was compromised.An 8fr flexima apdl drainage catheter was received with the package opened along its length.The device was not useable.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event was approximated as event date was not reported.Device analysis by mfr: visual inspection was performed on the returned device.The device was returned within the original un-opened pouch.The pouch was damaged and opened along its length.The damage observed is consistent with mechanical cut in the pouch surface.The integrity of the device inside the pouch was without issues.

• 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: 10309609
• Report Number: 2134265-2020-09702
• Device Sequence Number: 3246898
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 03/04/2023
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0025307145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1