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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); 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: 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 in 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. Medical device expiration date: unknown. 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.
 
Event Description
It was reported that 29 unspecified bd safetyglide¿ syringe needles were clogged during use, 15 needles detached from their syringe, 7 needles pulled out of their hubs, 6 syringes leaked, and 1 syringe's safety system did not close. Additionally, 9 needles caused dirty needle sticks prior to safety activation, and 1 needle caused a dirty needle stick after the safety mechanism activation. This complaint was created to capture the 1st 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 (9), needlestick injury after patient use after safety mechanism activation (locked over needle) (1), needle clogged (29), needle detaches from syringe (15), unable to aspirate medications (50), needle dull/blunt (30), scale marking missing/illegible (2), needle pulled out of hub (7), leakage (6), needle bent (30), safety system did not close (1). Additional information related to what leaked and from where states: "meds" "needle" additional information related to nsi prior to use states: "the patient sort of moved abruptly with their blanket hitting care giver and resulting in syringe falling off care giver's hand while trying to activate the safety lock post administration" additional information related to nsi after to use states: "safety mechanism was not totally locked" additional clinical/pt impact information related to nsi prior to use states: "body fluid" additional clinical/pt impact information related to nsi after to use states: "safety mechanism was not locked" additional clinical/pt impact information related to unable to aspirate medications states: "syringe locked and aspiration was difficult" additional clinical/pt impact information related to scale marking missing/illegible states: "exposure"".
 
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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 Key11631685
MDR Text Key257417839
Report Number2243072-2021-00984
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
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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