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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTLOOK®; SET, ADMINISTRATION, INTRA
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OUTLOOK®; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 354214
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/18/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number was provided for evaluation; however, b.Braun has initiated a voluntary medical device correction for multiple batches of outlook® pump sets.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.
 
Event or Problem Description
As reported by the user facility: the nursing units confirmed that they have experienced leaking from the cassette.No injury reported.
 
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Brand Name
OUTLOOK®
Common Device Name
SET, ADMINISTRATION, INTRA
MDR Report Key12419054
Report Number2523676-2021-00283
Device Sequence Number14352974
Product Code FPA
UDI-Device Identifier04046964182235
UDI-Public04046964182235
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K083723
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 09/02/2021
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 Number354214
Device Catalogue Number354214
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2021
Initial Report FDA Received Date09/02/2021
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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