MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number NBI0701400

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number: 81396966.

Event Description

According to the available information, the internal packaging of the needle was torn / compromised.

Manufacturer Narrative

Lot number: 81396966.

Event Description

According to the available information, the internal packaging of the needle was torn / compromised.

• Brand Name: BONEE NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13046211
• MDR Text Key: 286134888
• Report Number: 9610711-2021-00124
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 03600040272930
• UDI-Public: 03600040272930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NBI0701400
• Device Catalogue Number: NBI070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• 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