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

Device Problems Defective Device (2588); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

Patient reported that the new shipment of mini spikes that she got also did not have airtight packaging and therefore patient has concerns about sterility of the supplies.Pharmacist sent email to appropriate escalations and management teams to contact patient to discuss manufacturing concerns.Patient does have 18g needles to use in the meantime to infuse her cuvitru.Patient did not miss a dose or experience an adverse event as a result of the defective product.Defective product lot number and expiration date unknown.Patient does have the defective product on hand for possible return to the manufacturer.No further information provided.Reported to (b)(6) by patient/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL AG
• MDR Report Key: 16903171
• MDR Text Key: 315034297
• Report Number: MW5117421
• Device Sequence Number: 1
• Product Code: LHI
• 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: 05/03/2023

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
• 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