MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG MINI SPIKE DISP PIN DP18C0SC; SET, I.V, FLUID TRANSFER

Lot Number 0061632338

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Received spontaneous email from field nurse to report that one of the spikes was defective.Spike did not have an opening ¿ it was closed off; it was all plastic so she could not aspirate fluid into the syringe using the spike lot#0061632338.Expiration date: 8/31/2023, no other information provided.Diagnosis or reason for use: pah.

• Brand Name: MINI SPIKE DISP PIN DP18C0SC
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 8189744
• MDR Text Key: 131476783
• Report Number: MW5082404
• 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: 12/05/2018

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 Operator: No Information
• Device Expiration Date: 08/31/2023
• Device Lot Number: 0061632338
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1