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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFSITE®; SET, ADMINISTRATION, INTRA
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B. BRAUN MEDICAL INC. SAFSITE®; SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 415067
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/20/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).It was confirmed that a sample and/or lot is not available.Without the actual device, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
 
Event or Problem Description
As reported by the user facility: customer reports that the anti reflux valve disconnects from spiros at the patients iv site.End user is using a filtered extension and our reflux valve which is attached to a spiros.The spiros often disconnects from the anti reflux valve which it should lock on.No injury reported.
 
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Brand Name
SAFSITE®
Common Device Name
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key8714482
Report Number2523676-2019-00101
Device Sequence Number11334302
Product Code FPA
UDI-Device Identifier04022495769855
UDI-Public04022495769855
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K942988
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/19/2019
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 Catalogue Number415067
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2019
Initial Report FDA Received Date06/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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