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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE WITH NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 309626
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd¿ tuberculin syringe with bd precisionglide¿ detachable needle pulled out of the hub, ¿popped off¿ when drawing up allergen medication during use. No reports of serious injury or medical intervention noted.
 
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Brand NameBD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7443412
MDR Text Key106732747
Report Number1213809-2018-00218
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number309626
Device Lot Number6305942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2018 Patient Sequence Number: 1
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