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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER
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B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER Back to Search Results
Catalog Number 456003
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 and lot number.Without the actual device and/or lot number, a thorough investigation could not be performed.Review of the discrepancy management system database was unable to be performed because the lot was reported as unknown.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: leakage of chemotherapy during chemo embolization.No injuries reported.
 
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Brand Name
DISCOFIX®
Common Device Name
ACCESSORIES, CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key6828343
Report Number2523676-2017-00123
Device Sequence Number58647
Product Code KGZ
UDI-Device Identifier04046964183577
UDI-Public04046964183577
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K760383
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 08/01/2017
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 Number456003
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/01/2017
Initial Report FDA Received Date08/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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