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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Complete Blockage (1094); Leak/Splash (1354)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: 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. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used. Device expiration date: unknown. Initial reporter phone #: an additional phone # was provided as (b)(6). Device manufacture date: unknown. 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. Investigation conclusion: no photos or samples were received for evaluation. Since no samples displaying the reported condition were received a potential root cause could not be defined. Since no samples displaying the reported condition were received corrective actions are not necessary.
 
Event Description
It was reported that unspecified bd safetyglide needle experienced a clogged/blocked needle, and the needle and syringe separating/spinning out. The following information was provided by the initial reporter: material no: unknown, batch no: unknown. It was reported via survey response that the clinician experienced needle clogged (1), needle pulled out of hub (1).
 
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Brand NameUNSPECIFIED BD SAFETYGLIDE SYRINGE
Type of DeviceSYRINGE
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 Key11632416
MDR Text Key244378196
Report Number2243072-2021-01014
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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

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