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

Model Number DP1800SC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

Spontaneous.Patient stated that she forgot to wipe her spike before she drew her medication and wanted to know if she should discard it.She also mentioned that it looks like her current remodulin vial/spike is leaking.Informed patient to discard the medication she draw since she 'aseptic techniques were not used' and don't want to risk infection.The patient doesn't have any medication left on current vial but still have 1 unopened vial with spike.Informed her to use new spike with new vial and draw 6 ml for today's mix.Reported to (b)(4) by pt/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 12481574
• MDR Text Key: 272299205
• Report Number: MW5104017
• Device Sequence Number: 1
• Product Code: LHI
• 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: 09/13/2021

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
• Device Model Number: DP1800SC
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR