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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTENSION SET; SET, ADMINISTRATION, INTRA
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EXTENSION SET; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 470195
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/11/2021
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: event 3: during chemotherapy, end user observed the leaking coming up and out of the caresite.Infusion leaks around injection port closest to patient.No injury reported.
 
Additional Manufacturer Narrative
Event 3: this report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible.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
MDR Report Key12039787
Report Number2523676-2021-00198
Device Sequence Number19814912
Product Code FPA
UDI-Device Identifier04046964823428
UDI-Public04046964823428
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K153293
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
Type of Report Initial,Followup
Report Date (Section B) 09/19/2021
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 Number470195
Device Catalogue Number470195
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 06/16/2021
Supplement Date Received by Manufacturer06/16/2021
Initial Report FDA Received Date06/22/2021
Supplement Report FDA Received Date09/19/2021
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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