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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 354216
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/29/2021
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 via medwatch mw5102935: "blood leaked from the tubing at the round area of the cassette." no injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.As a result of this issue, 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
OUTLOOK®
Common Device Name
SET, ADMINISTRATION, INTRA
MDR Report Key12419053
Report Number2523676-2021-00286
Device Sequence Number19733456
Product Code FPA
UDI-Device Identifier04046964182273
UDI-Public04046964182273
Combination Product (Y/N)N
PMA/510(K) Number
K083723
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 10/23/2021
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 Expiration Date12/31/2023
Device Model Number354216
Device Catalogue Number354216
Device Lot Number0061765128
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/23/2021
Supplement Date Received by Manufacturer08/23/2021
Initial Report FDA Received Date09/02/2021
Supplement Report FDA Received Date10/23/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured01/28/2021
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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