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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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B. BRAUN MEDICAL INC. IV ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number V1415-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hepatitis (1897); Nausea (1970); Vomiting (2144)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
This report has been identified as event fifteen of b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
 
Event Description
As reported per health (b)(6) inquiry (hc #(b)(4)): six (6) patients presented to a local emergency department within 24 hours of receiving an infusion of vitamins from a naturopath. They presented with various degrees of symptoms including flu-like symptoms, diarrhea, nausea and hepatitis. All patients who received this treatment were then interviewed and 17 of the 18 developed symptoms from 30 minutes to 24 hours after the infusion. All have recovered. The investigation expanded to include another city in which this naturopath practiced, and more cases were identified with similar symptom complex and timing. The product was confiscated under the health protection act with proper chain of custody. They are continuing their investigation to determine whether this is a batch issue , a practice safety issue, or other. A report is being filed for each of the patients who exhibited symptoms, as each patient would represent a separate event, for a total of 17 events. This report is being filed for event 15.
 
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Brand NameIV ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown,
Manufacturer (Section G)
B. BRAUN DOMINICAN REPUBLIC, INC.
las americas industrial park
km22 autopista las americas
santo domingo,
DR
Manufacturer Contact
jonathan severino
861 marcon boulevard
allentown, pa 
2408332
MDR Report Key10379150
MDR Text Key202036606
Report Number2523676-2020-00228
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberV1415-15
Device Lot Number0061717018
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/07/2020 Patient Sequence Number: 1
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