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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 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs and the transfer set have been received for evaluation.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 a slightly skewed valve on the transfer set.They installed the transfer set and then failed the leak test several times.No patient involvement.The user replaced the transfer set with no further issues.
 
Event Description
As per user facility: customer reported a slightly skewed valve on the transfer set.They installed the transfer set and then failed the leak test several times.No patient involvement.The user replaced the transfer set with no further issues.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Apex technical support confirmed the leak check event from the device logs.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 set was vacuum leak tested per specification with passing results.Visual examination of a retained unit noted no visual defects.The set was vacuum leak tested per specification with passing results.A review of our discrepancy management system database found no related or similar discrepancies during the production of the batch.Based on the results of the investigation this complaint is not confirmed for valve misalignment.B.Braun will continue to investigate, trend, and monitor all complaints of this nature.If additional pertinent information becomes available a follow-up report will be filed.
 
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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 Key7709824
MDR Text Key114678044
Report Number1641965-2018-00013
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
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 Manufacturer06/28/2018
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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