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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VACUTAINER ADAPTER WITH LUER ADAPTER; TUBE ADAPTER WITH LUER CONTAINER
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BD BD VACUTAINER ADAPTER WITH LUER ADAPTER; TUBE ADAPTER WITH LUER CONTAINER Back to Search Results
Catalog Number 367300
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/20/2014
Event Type  Injury  
Event Description
It was reported that a bd vacutainer adapter with luer adapter was placed onto a patient's dialysis catheter.When the adapter was removed ti snapped leaving the plastic luer adapter inside the patient's dialysis catheter.This resulted in a patient needing a new dialysis catheter.The patient underwent a radiological procedure to hae a new tunneled dialysis line placed and was admitted to the hospital overnight.
 
Manufacturer Narrative
Results - a sample was not received for evaluation and a lot number for this device was not provided.Without a lot number for this device a review of the device history records could not be performed.Conclusion: without a sample, a root cause for this incident could not be identified.
 
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Brand Name
BD VACUTAINER ADAPTER WITH LUER ADAPTER
Type of Device
TUBE ADAPTER WITH LUER CONTAINER
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417 188
Manufacturer Contact
aaron larson
1 becton dr.
franklin lakes, NJ 07417-1880
8015652406
MDR Report Key4279011
MDR Text Key20778359
Report Number2243072-2014-00292
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeUK
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 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number367300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2014
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
Patient Outcome(s) Hospitalization; Required Intervention;
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