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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC APEX¿; COMPOUNDER
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B. BRAUN MEDICAL INC APEX¿; COMPOUNDER Back to Search Results
Model Number AX1000
Device Problem Failure to Align (2522)
Patient Problem No Patient Involvement (2645)
Event Date 11/09/2018
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number(b)(4).The device logs have been received.The transfer set has not been returned for evaluation at this.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
 
Event Description
As per user facility: customer reported the leak check was failing.Customer indicated the valve on station m1 is skewed.It was noticed prior to installing the transfer set but the set was still installed.No patient involvement.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs have been received.The log review did not confirm an occurrence of a skewed valve.One (1) used set, with packaging, was returned for evaluation.Visual examination of the set noted the set was used, and no visual defects were noted.The reported defect of skewed valve was not confirmed.If additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
As per user facility: customer reported the leak check was failing.Customer indicated the valve on station m1 is skewed.It was noticed prior to installing the transfer set but the set was still installed.No patient involvement.
 
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Brand Name
APEX¿
Type of Device
COMPOUNDER
Manufacturer (Section D)
B. BRAUN MEDICAL INC
1601 wallace drive, suite 150
carrollton TX 75006 6690
MDR Report Key8073217
MDR Text Key128405526
Report Number1641965-2018-00023
Device Sequence Number1
Product Code NEP
UDI-Device Identifier04046955048502
UDI-Public(01)04046955048502
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 12/27/2018
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
Device Operator Health Professional
Device Model NumberAX1000
Device Catalogue NumberAX1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Initial Date Manufacturer Received 11/09/2018
Initial Date FDA Received11/15/2018
Supplement Dates Manufacturer Received11/09/2018
Supplement Dates FDA Received12/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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