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

Model Number M001274020

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported the flexima drainage catheter was received with a torn package.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the seal damage (torn), near the printed label.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

It was reported the flexima drainage catheter was received with a torn package.

• 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: 4343072
• MDR Text Key: 5179580
• Report Number: 2134265-2014-08027
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2017
• Device Model Number: M001274020
• Device Catalogue Number: 27-402
• Device Lot Number: 17216210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1