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

Catalog Number	412000
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.Without the actual device, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
Per medwatch number (b)(4).Event description: in-patient was brought to mri for an abdominal mri with contrast.Mri power injector was filled and primed.Patency of antecubital peripheral intravenous line was confirmed with saline injection and the peripheral iv line was connected to the automated contrast-injector.After mr imaging was performed, the technologist noticed that there was no sign of contrast-administration on obtained images.The patient was evaluated and was not symptomatic, and no infiltration of contrast was identified in the soft tissues.When the contrast-injector syringe was evaluated, air was noted in the syringe that should have contained contrast material.It was therefore assumed that an injection of 10cc of air into the peripheral intravenous line had occurred.At approximately 0815, the attending neuroradiologist, was notified.The patient was removed from the mri room, evaluated and placed in a left-side down decubitus and in trendelenburg (head-down) position.While in the mri department for the next 45 minutes, blood pressure, heart rate and pulse oximetry were monitored and remained stable.The patient was asymptomatic.The attending meuroradiologist notified the patient's in-hospital physician of record, who also evaluated the patient in the mri department.After a brief discussion, including telephone consultations with the on-call cardiac anesthesiologist, it was decided to transfer the patient for further observation to the post-procedure observation unit of the department of diagnostic imaging at approximately 0900.

• Brand Name: MINI-SPIKE®
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9244992
• Report Number: 2523676-2019-00188
• Device Sequence Number: 19482977
• Product Code: LHI
• UDI-Device Identifier: 04022495769619
• UDI-Public: 04022495769619
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2023
• Device Catalogue Number: 412000
• Device Lot Number: 0061656792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR