MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA¿; TUBE, DRAINAGE, SUPRAPUBIC

Model Number M001271790

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During unpackaging of a flexima drainage catheter, the staff opened the package and it ripped down the plastic in a way that it shouldn't have opened.So it contaminated the drain.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: unit returned with its original pouch batch (b)(4).A visual examination identified the catheter and metal cannula were received within its original pouch, however the metal cannula was received bent, and the pouch is broken at the section where the metal cannula is bent.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

During unpackaging of a flexima drainage catheter, the staff opened the package and it ripped down the plastic in a way that it shouldn't have opened.So it contaminated the drain.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: FLEXIMA¿
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5061532
• MDR Text Key: 25194432
• Report Number: 2134265-2015-06232
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Model Number: M001271790
• Device Catalogue Number: 27-179
• Device Lot Number: 17873121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1