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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE PISTON SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Complete Blockage (1094); Leak/Splash (1354); Delivered as Unsterile Product (1421); Material Protrusion/Extrusion (2979)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 55 unspecified bd safetyglide¿ syringe needles clogged during use, 33 were unable to inject medicine, 50 needles detached from their syringes, 34 needles pulled out of their hubs, 1 syringe leaked, and 10 syringes' safety systems would not close. Additionally, 2 needles caused dirty needle stick injuries prior to safety mechanism activation, and 10 needles caused dirty needle stick injuries when the safety mechanism had already been activated. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: "it was reported via survey response that the clinicians experienced needlestick injury after patient use prior to safety mechanism activation (2), needlestick injury after patient use after safety mechanism activation (locked over needle) (10), needle clogged (55), unable to inject medications (33), needle detaches from syringe (50), unable to aspirate medications (9), needle dull/blunt (2), scale marking missing/illegible (15), needle pulled out of hub (34), leakage (1), needle bent (15), safety system did not close (10). Additional information related to what leaked and from where states: "insulin" "i don't recall". Additional information related to nsi prior to use states: "the needle went through the base and i pricked myself". Additional information related to nsi after to use states: "injuries to the fleshy part of the fingers. "".
 
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Brand NameUNSPECIFIED BD SAFETYGLIDE SYRINGE
Type of DevicePISTON 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11631740
MDR Text Key261307169
Report Number2243072-2021-00986
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
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 Received03/11/2021
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: 04/07/2021 Patient Sequence Number: 1
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