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

Model Number DP1800SC

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Patient reported there is no opening for the medication to come out/be dispensed.The other mini spikes on hand are all okay per patient.No other issues reported.No missed doses or adverse events reported; expiration date is unknown; patient does have the defective product on hand for possible return to manufacturer.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 AG
• MDR Report Key: 16832758
• MDR Text Key: 314282191
• Report Number: MW5117101
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 04/21/2023

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 Model Number: DP1800SC
• Device Lot Number: 0061852574
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Patient Sequence Number: 1
• Patient Sex: Female