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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI-SPIKE®; SET, I.V. FLUID TRANSFER
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B. BRAUN MEDICAL INC. MINI-SPIKE®; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 412012
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/16/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number was available for further evaluation.Without the actual device and/or lot number, 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
As reported by the user facility: it was reported that after drawing up propofol into a syringe using b.Braun 412012 dispensing pin, small blue particles were seen floating in the propofol.No injury reported.
 
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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 Key9457801
Report Number2523676-2019-00231
Device Sequence Number19593079
Product Code LHI
UDI-Device Identifier04022495769671
UDI-Public04022495769671
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K925401
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/12/2019
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 Catalogue Number412012
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2019
Initial Report FDA Received Date12/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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