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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); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007); Patient Device Interaction Problem (4001)
Patient Problems Bacterial Infection (1735); 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 for this field. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: as the material and lot numbers were unknown for this incident and samples were unavailable for return, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that unspecified bd safetyglide syringe experienced 12 cases of leakage, 2 cases of dirty needle stick injury, 1 case of bloodstream infection, 10 cases of clogged/blocked needles, 1 case of foreign matter contamination, and 8 cases of damaged/open unit packaging/seals where sterility was compromised. It has not been specified whether medical intervention was applied as a result of the dirty needle stick injuries. 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 exposure to body fluid or blood (12), leakage (12), bloodstream infection (blood stream bacteraemia, sepsis etc. ) (1), needlestick injury before use on patient (12), needlestick injury after use on patient (2), syringe needle connectivity issue (1), needle clogged (10), foreign matter in fluid path (1), foreign matter in packaging (4), package open before use / damaged packaging (8), needle dull (4), needle bent (5). Additional information related to the clinician's exposure to blood. : "an accidental puncture with clean and used needles. " additional information related what leaked and from where states: "blood" "the needle system. " additional information related to needlestick prior to use states: "a surface injury. ".
 
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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 Key11635084
MDR Text Key244945910
Report Number2243072-2021-01020
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,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
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

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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