MAUDE Adverse Event Report: MEDI-GLOBE GMBH CLICK TIP INJECTION NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Lot Number G1826768

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/14/2020

Event Type  Injury  

Event Description

The click-tip injection needle was used to control bleeding after sphincterotomy was performed during ercp.At first 1/2cc epinephrine was injected thru click-tip then needle was withdrawn back into sheath.Second time needle was deployed it came out side of sheath.Click-tip was removed from scope and a different click tip had to be used.Fda safety report id # (b)(4).

• Brand Name: CLICK TIP INJECTION NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): MEDI-GLOBE GMBH
• MDR Report Key: 10777919
• MDR Text Key: 214562126
• Report Number: MW5097617
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Lot Number: G1826768
• Was Device Available for Evaluation?: 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: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR