MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FILTER STRAW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number 415021

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 08/06/2021

Event Type  malfunction  

Event Description

When the rn opened the package to use the filter needle.The product was broken in the package.

• Brand Name: FILTER STRAW
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 12376924
• MDR Text Key: 268457834
• Report Number: 12376924
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 415021
• Device Catalogue Number: 415021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1