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

Model Number DP1800SC

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

Spontaneous call from patient who reported just now while she was creating a new mix, the "plunger part of the mini spike fell into the bottle of treprostinil and there is no way for her to get it back out" she v/u.She has 3 more vials of treprostinil on hand so she was able to use another vial.She provided the following regarding unusable treprostinil vial: lot number 884061 and malf mini spikes: lot numbers 0061798384 and 0061804410.She is not sure which one is the actual lot number for the 'malf' mini spike.Unknown if her doctor is aware of this event.Unknown if defect vial and mini spike available for return.No adverse event from defective device reported.No other information provided.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 / B. BRAUN MELSUNGEN AG
• MDR Report Key: 13677715
• MDR Text Key: 286852189
• Report Number: MW5107909
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DP1800SC
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female