MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B. BRAUN D500 MEDICAL 4-WAY STOPCOCK; ACCESSORIES, CATHETER

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

Event Type  Injury  

Event Description

Device was utilized by the patient and has had multiple issues with broken stopcocks.

• Brand Name: B. BRAUN D500 MEDICAL 4-WAY STOPCOCK
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 18885148
• MDR Text Key: 337539419
• Report Number: MW5152610
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White