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

Model Number	32375
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: populated as (b)(6) 2018 as there is no known event date.Populated as the first day of the month of the bsc aware date.
Event or Problem Description
It was reported that the device sterility was compromised.Four vtc/10.3 flexima drainage catheters were drop ship to the end user.After checking the items in the box, it was noted that the inside of the product, not the box, were damaged with tears in them.The packaging of the items were torn open.There was no patient involvement reported.
Additional Manufacturer Narrative
Date of event - populated as (b)(6) 2018 as there is no known event date.Populated as the first day of the month of the bsc aware date.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 04:13 pm ct.The report number is being corrected from: 2134265-2018-64071 to: 2134265-2018-62342.
Event or Problem Description
It was reported that the device sterility was compromised.Four vtc/10.3 flexima drainage catheters were drop ship to the end user.After checking the items in the box, it was noted that the inside of the product, not the box, were damaged with tears in them.The packaging of the items were torn open.There was no patient involvement reported.The device was returned for evaluation.The device had a damaged pouch noted upon overall visual revision.The pouch has evidence of manipulation, was bent and has wrinkles.The pouch has a perforation in the clear plastic exposing the device and with the label damaged (tear).No other issues reported.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8010093
• Report Number: 2134265-2018-62342
• Device Sequence Number: 13779692
• Product Code: GBO
• UDI-Device Identifier: 08714729323310
• UDI-Public: 08714729323310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 08/27/2021
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0022577828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1