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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MULTI-AD; DISPENSER, LIQUID MEDICATION
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B. BRAUN MEDICAL INC. MULTI-AD; DISPENSER, LIQUID MEDICATION Back to Search Results
Model Number 513506
Device Problems Particulates (1451); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2023
Event Type  malfunction  
Event Description
Pharmacy tech was processing an intravenous sterile compound product that required reconstitution with sterile water.The sterile water set-up requires a [redacted name] multi-ad fluid dispensing system.The pharmacy tech opened the sterile package containing the dispensing set, when they noticed a black blemish/mark on the tip of the transfer spike/needle.The pharmacy tech did not use this potential defective product.The product was quarantined and reported to the pharmacist.This event, product, lot number and expiration date were reported to the manufacturer [redacted name].
 
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Brand Name
MULTI-AD
Type of Device
DISPENSER, LIQUID MEDICATION
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key17190417
MDR Text Key317749158
Report Number17190417
Device Sequence Number1
Product Code KYX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/13/2023
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 Model Number513506
Device Catalogue Number513506
Device Lot Number0061865456
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/13/2023
Event Location Hospital
Date Report to Manufacturer06/23/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/23/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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