MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA ALL PURPOSE DRNG LOOP CATHETER; TUBE, DRAINAGE, SUPRAPUBIC

Catalog Number M001271380

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  Injury  

Event Description

Tube separated near valve in an area uncommon for tube/catheter to separate.

• Brand Name: FLEXIMA ALL PURPOSE DRNG LOOP CATHETER
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 8042236
• MDR Text Key: 126496815
• Report Number: MW5081074
• Device Sequence Number: 0
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M001271380
• Device Lot Number: 21091453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 64