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

Model Number 412012

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Based on the data from the investigation we are unable to determine the root cause of the reported incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.  if any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: it was reported that when the end user inverted the vial to check the integrity, some of the chemotherapy leaked onto the thumb of her right hand.No injury reported.

• Brand Name: MINI-SPIKE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, pa ; 7197287
• MDR Report Key: 10104920
• MDR Text Key: 193108325
• Report Number: 2523676-2020-00149
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04022495769671
• UDI-Public: 04022495769671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2020

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: Health Professional
• Device Model Number: 412012
• Device Catalogue Number: 412012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1