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

Lot Number 0061732629

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

Received a spontaneous call from the patient, three of the mini spike dispensing pins: lot number 0061732627, expiration 04/30/2025 were not able to release air into the diluent vial as a result, he was not able to draw up his diluent.Per the patient, he had extra spikes on hand and was able to complete his mix.Patient does have the spikes available in case the manufacture wants them for evaluation.No additional information was provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE CISPENSE PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 11071913
• MDR Text Key: 223737741
• Report Number: MW5098518
• 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: 12/14/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0061732629
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1