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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. SAFSITE®; SET, ADMINISTRATION, INTRA
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B. BRAUN DOMINICIAN REPULIC INC. SAFSITE®; SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 471987
Device Problem Fluid/Blood Leak (1250)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2019
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
 
Event Description
As reported by the user facility: it was reported that the set detached and patient had 2ml of blood loss.
 
Manufacturer Narrative
Two (2) used samples were returned for evaluation.After a visual inspection was performed, it was noted that the two samples appeared to be connected to non-b.Braun valves.The two sets were tested per specification with passing results.The reported defect was unable to be confirmed through sample evaluation.If a sample and/or any additional pertinent information becomes available, a follow-up will be submitted.
 
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Brand Name
SAFSITE®
Type of Device
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN DOMINICIAN REPULIC INC.
las americas industrial park
km22 autopista las americas
DR 
MDR Report Key9411680
MDR Text Key169244911
Report Number9614279-2019-00210
Device Sequence Number1
Product Code FPA
UDI-Device Identifier04046963790110
UDI-Public04046963790110
Combination Product (y/n)N
PMA/PMN Number
K954123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number471987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Date Manufacturer Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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