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

Catalog Number DP1800SC

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous report from patient reporting that when she spiked a vial of treprostinil using the minispike dp1800sc, the rubber stopper was forced into the medication vial and the medication was left unsterile.The patient discarded the spike and vial, so the exact lot number of the medication was unknown.She stated this is the second time this has happened to her (last date of occurrence unknown).Will request a replacement vial.No other information known.Specific lot numbers unknown due to patient discarding.No other information is known.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: 15690444
• MDR Text Key: 302780617
• Report Number: MW5112920
• 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: 08/26/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DP1800SC
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female