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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFEDAY¿; SET, ADMINISTRATION, INTRA
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B. BRAUN MEDICAL INC. SAFEDAY¿; SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 415108
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
As reported by the user facility: blood leakage is occurring while attaching the safeday valve to the introcan safety 3.A small amount of blood leaks during connecting, and occurs after the dressing is applied or at the time of the catheter removal.This has been occurring intermittently, with one clinician reporting the issue several times.No injury reported.
 
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Brand Name
SAFEDAY¿
Common Device Name
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown 18109
MDR Report Key8603022
Report Number2523676-2019-00033
Device Sequence Number2372331
Product Code FPA
UDI-Device Identifier04046964296215
UDI-Public04046964296215
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K955585
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) 05/13/2019
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 Number415108
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2019
Initial Report FDA Received Date05/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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