MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. MINI SPIKE DISP PIN; SET, I.V. FLUID TRANSFER

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

Patient stated the spike the pharmacy sent her was loose due to the fact the medication was leaking, also stated she had hard time handling bottle and spike at the same time.Incident happened on (b)(6) 2020.Patient did not provide lot number.No further information is provided.The patient did not miss any doses or experience any adverse events.The patient does not have the product on hand.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 10200265
• MDR Text Key: 196952436
• Report Number: MW5095234
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2020
• Patient Sequence Number: 1
• Patient Age: 39 YR