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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA
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BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 477005
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/25/2021
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 the blood set leaked.No injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although no sample was provided for evaluation, as a result of other confirmed complaints of this nature, b.Braun has initiated a voluntary medical device correction for multiple batches of outlook® pump sets including the batch identified from this complaint.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
BLOOD ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRA
MDR Report Key12172287
Report Number2523676-2021-00211
Device Sequence Number1631845
Product Code FPA
UDI-Device Identifier04046955202799
UDI-Public04046955202799
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K140311
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 08/30/2021
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 Number477005
Device Catalogue Number477005
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/06/2021
Supplement Date Received by Manufacturer07/06/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date08/30/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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