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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BBRAUN MEDICAL ADDEASE BINARY CONNECTOR WITH 17 GA NEEDLE; BBRAUN CONNECTOR
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BBRAUN MEDICAL ADDEASE BINARY CONNECTOR WITH 17 GA NEEDLE; BBRAUN CONNECTOR Back to Search Results
Model Number N7995
Device Problems Leak/Splash (1354); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)
Patient Problem No Code Available (3191)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
This is being reported voluntarily as a quality and safety concern.There have been six (6) bags of ivpb bags with issues beginning (b)(6) 2014, as the first indication.Two (2) are unable to activate the powder from the vial to be mixed with the nacl bag.Two (2) lake outside of the vials.Two (2) drip back into the vial.All are resulting in an inaccurate volume/dose being delivered to the patient.When the bag leaks, the staff calls pharmacy for another bag.The volume infused/wasted is inaccurate when the next bag is mixed.What is consistent is the saline ivpb bag and the bbraun connector that connects the vial to the ivpb.There are different size vials and different iv antibiotics with these six bags.In fact, five of six are different meds.(b)(4).
 
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Brand Name
ADDEASE BINARY CONNECTOR WITH 17 GA NEEDLE
Type of Device
BBRAUN CONNECTOR
Manufacturer (Section D)
BBRAUN MEDICAL
824 12th ave
bethlehem PA 18018
MDR Report Key4438022
MDR Text Key5392727
Report NumberMW5040241
Device Sequence Number1
Product Code LHI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2015
2 Devices were Involved in the Event: 1   2  
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 NumberN7995
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/15/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REF BC200 GREEN CAPS 20MM WITH PAB CONTAINERS; REF N7995 GREEN CAPS 20MM WITH EXCELL CONTAINERS
Patient Outcome(s) Other;
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