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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE

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BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Positioning Problem (3009)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4). Device manufacture date: unknown investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Unable to perform dhr due to unknown lot number. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
 
Event Description
It was reported that when activating the safety shield on a unspecified bd¿ insulin syringe that was used for a shingles injection, the needle snapped to the side and stuck the finger of the pharmacist. The pharmacist went to the hospital where they were tested for hiv and hpv.
 
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Brand NameUNSPECIFIED BD¿ INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8052403
MDR Text Key126631287
Report Number2243072-2018-01605
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2018
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 Treatment Data
Date Received: 11/08/2018 Patient Sequence Number: 1
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