MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE FOR BLADDER INJECTION; ENDOSCOPIC NEEDLE, GENERAL-PURPOSE, SINGLE-USE

Catalog Number NBI035

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

According to the available information prior to use, the needle broke in the albarran instrument.

• Brand Name: BONEE NEEDLE FOR BLADDER INJECTION
• Type of Device: ENDOSCOPIC NEEDLE, GENERAL-PURPOSE, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18970733
• MDR Text Key: 338509490
• Report Number: 9610711-2024-00073
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 03600040250174
• UDI-Public: 3600040250174
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NBI035
• Device Lot Number: 9260691_NBI0351002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 08/03/2023
• 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