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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; CATHETER, CONDUCTION, ANESTHETIC
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B. BRAUN MEDICAL INC.; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Catalog Number 7JC1903
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 Description
As reported by the user facility: event 1: p/n: 7jc1903.Lot: 0061874016.Complaint: rn brought to my attention an issue with the epidural catheters that happened a couple of times last week (as they indicated).The catheter was found broken apart and could not be used at time of a section, which was then managed by a spinal.This was not a disconnection issue from the hub (which we encountered before).I tested one of those catheters myself to find them break down apart with minimal effort which is very concerning.No injury reported.
 
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Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key18509002
MDR Text Key333208551
Report Number2523676-2024-00009
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7JC1903
Device Lot Number0061874016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/26/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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