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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRA
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B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 470073
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
This report has been identified as b.Braun medical internal report number (b)(4).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: it was reported that during chemotherapy blinatumomab, the filter leaked.No injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).  based on the data from the investigation we are unable to determine the root cause of the reported incident.  we will maintain this report for further references and continue to monitor other reports for similar occurrences.  if any additional pertinent information becomes available, a follow up will be submitted.
 
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Brand Name
EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
MDR Report Key10397413
Report Number2523676-2020-00211
Device Sequence Number14129378
Product Code FPA
UDI-Device Identifier04046964298219
UDI-Public04046964298219
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K942988
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/27/2020
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 Model Number470073
Device Catalogue Number470073
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/22/2020
Supplement Date Received by Manufacturer07/22/2020
Initial Report FDA Received Date08/12/2020
Supplement Report FDA Received Date08/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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