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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE®; SET, ADMINISTRATION, INTRA
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B. BRAUN MEDICAL INC. CARESITE®; SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 415122-01
Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
 
Event Description
As reported by the user facility: it was reported that during morning blood sample routine, air bubbles were noted in the tubing, and the dressing was stained with blood at the anti-reflux valve.A more experienced nurse was called and she noticed that while trying to screw the valve back, there was a crack in the valve.
 
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Brand Name
CARESITE®
Type of Device
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key12544860
MDR Text Key273772428
Report Number2523676-2021-00331
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number415122-01
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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