MAUDE Adverse Event Report: COLOPLAST A/S MANUFACTURING FRANCE, SAS BONEE BLADDER INJECTION NEEDLE 70

Model Number NBI0701002

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Per complaint received, the dr found small blue particle in the urine/bladder of the pt.He noted that the inscription of the needle peeled off during the manipulation with the cystoscope.

Manufacturer Narrative

Coloplast received 1 used needle following complaint.Upon inspection of the needle, it was determined that the blue material is the inscription on the thermoplastic tubing which is connected to the needle.Complaint can be confirmed as reported.

• Brand Name: BONEE BLADDER INJECTION NEEDLE 70
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING FRANCE, SAS; 9 ave edmond rostard; sarlat la caneda 2420 6; FR 24206
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE, SAS; 9 ave edmond rostard; sarlat la caneda 2420 6; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4745096
• MDR Text Key: 5703345
• Report Number: 9610711-2015-00016
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• PMA/PMN Number: K090217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2018
• Device Model Number: NBI0701002
• Device Catalogue Number: NBI0701002
• Device Lot Number: 4334636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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
• Patient Outcome(s): Other