MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI SPIKE DISP. PIN; DISPENSER, LIQUID MEDICATION

Device Problems Fluid/Blood Leak (1250); Component Missing (2306); Defective Device (2588); Application Program Problem: Medication Error (3198)

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

Event Type  malfunction  

Event Description

Per (b)(6) states she went to withdraw 4ml of remodulin from a newly spiked vial when the drug spilled out onto her hands.States she immediately washed her hands after.States she was unable to withdraw remodulin from new vial.After troubleshooting measures were discussed, it was determined the new mini-spike (b)(6) had used to spike the new vial of remodulin was defective (mini-spike was missing the white side cap).(b)(6)inserted new mini spike into the remodulin vial and was then able to withdraw the medication.(b)(6) denies any adverse events from the drug spilling on her hands.(b)(6)denies rash or itching at site.Unknown how much drug was wasted.(b)(6) reports approximately 3-4ml.No missed dose.Defective product lot number and expiration date are unknown.Unknown if pt has the defective product on hand for possible return to the manufacturer.Reported (b)(6) by: health professional.

• Brand Name: MINI SPIKE DISP. PIN
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16984024
• MDR Text Key: 315858575
• Report Number: MW5117761
• Device Sequence Number: 1
• Product Code: KYX
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Sex: Female