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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VACUTAINER MULTISAMPLE BLOOD COLLECTION; BLOOD COLLECTION NEEDLE
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BD BD VACUTAINER MULTISAMPLE BLOOD COLLECTION; BLOOD COLLECTION NEEDLE Back to Search Results
Catalog Number 360211
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414)
Event Date 03/06/2014
Event Type  Injury  
Event Description
On (b)(6) 2014, the reporter stated that on (b)(6) 2014, the pt experienced an allergic reaction on venipuncture site.Additional info receive via email from the country coordinator on (b)(6) 2014, the venipuncture was performed for a health test so no medication is infused.However, the pt saw a doctor, who dispensed medication for the allergy.It was unk, if the rash resolved.But nothing further was heard from the customer it was believed that tht pt recovered.
 
Manufacturer Narrative
No product has been received to date.If product is returned, analysis will be conducted.Unable to run complaint history check or device history review as the lot number is unk.Quality will continue to monitor on monthly trend reports.
 
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Brand Name
BD VACUTAINER MULTISAMPLE BLOOD COLLECTION
Type of Device
BLOOD COLLECTION NEEDLE
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417
Manufacturer Contact
amy bodell
1 becton dr.
franklin lakes, NJ 07417-1880
8015652585
MDR Report Key3824469
MDR Text Key4393061
Report Number2243072-2014-00071
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number360211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/17/2014
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) Required Intervention;
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