MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG MINI SPIKED DISP PIN; SET, I.V, FLUID TRANSFER

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Spontaneous call pt was doing a mix and the spike is missing parts, so ended up leaking.Lot 0061671084.No other info known.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKED DISP PIN
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 9284671
• MDR Text Key: 165553348
• Report Number: MW5090883
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR