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

Lot Number 0061854091

Device Problems Defective Device (2588); Device Contaminated During Manufacture or Shipping (2969); Failure to Seal (4070)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Patient reports that mini spike packages are not air-tight, and are thus not sterile.No obvious damage to packaging.Other airtight items in her supply were still okay.Multiple lot numbers all manufactured by braun.Listed one, but the others ended in 432, 428, and 486.Patient will use 18gauge needles to transfer fluid until new airtight minispike packages can be sent.Unknown if the patient missed a dose or experienced an adverse event as a result of the defective product.Unknown defective product expiration dates.Unknown if the pt has the defective product on hand for possible return to the manufacturer.No further information.Reference report #mw5117397, #mw5117398, #mw5117399.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE IV DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16902025
• MDR Text Key: 314985552
• Report Number: MW5117396
• 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: 04/25/2023

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 Lot Number: 0061854091
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2023
• Patient Sequence Number: 1
• Patient Sex: Female