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

Model Number M001271300

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported there was the presence of filaments in the device packaging.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The unit returned has the label damaged, as part of overall visual revision.The device was received in the original pouch, the pouch was received opened and evidence of seal process was observed.Additionally, the pouch has a damaged label.No foreign matters were found in the pouch.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported there was the presence of filaments in the device packaging.

• Brand Name: FLEXIMA¿ APD¿
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7000559
• MDR Text Key: 92054909
• Report Number: 2134265-2017-10739
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: TN
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Model Number: M001271300
• Device Catalogue Number: 27-130
• Device Lot Number: 0017831865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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