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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESITE®; SET, ADMINISTRATION, INTRA
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CARESITE®; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 354205
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
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 particles were observed inside the drip chamber.No injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photographs were provided for evaluation.A visual evaluation was performed on photograph and it is difficult to determine the reported defect.Based on the data from the investigation no foreign contamination was observed via the photo.Retained units were evaluated and passed the internal testing.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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
CARESITE®
Common Device Name
SET, ADMINISTRATION, INTRA
MDR Report Key12172286
Report Number2523676-2021-00209
Device Sequence Number16552095
Product Code FPA
UDI-Device Identifier04046964182099
UDI-Public04046964182099
Combination Product (Y/N)N
Initial Reporter StateWY
Initial Reporter CountryUS
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 distributor,health profession
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/28/2021
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 Date01/31/2024
Device Model Number354205
Device Catalogue Number354205
Device Lot Number0061768446
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 Date08/28/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
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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