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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE; 3ML SYRING WITH NEEDLE
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BD BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE; 3ML SYRING WITH NEEDLE Back to Search Results
Catalog Number 305270
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
The needle detached in the injection site.An ultrasound was performed in the emergency room, which confirmed the needle was in the site.
 
Manufacturer Narrative
Additional information regarding the incident has been requested.A prepaid mailing label and shipping tube have been sent for return of the sample.Upon receipt of the sample and completion of the investigation, a supplemental report will be submitted, (b)(4).
 
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Brand Name
BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE
Type of Device
3ML SYRING WITH NEEDLE
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417
Manufacturer Contact
amy bodell
1 becton dr.
franklin lakes, NJ 07417
8015652585
MDR Report Key3854907
MDR Text Key4413286
Report Number2243072-2014-00114
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2012
Device Catalogue Number305270
Device Lot Number9272982
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/15/2014
Initial Date FDA Received05/28/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2009
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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