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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); Volume Accuracy Problem (1675); Material Protrusion/Extrusion (2979)
Patient Problem 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. 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. ".
 
Event Description
It was reported that unspecified bd safetyglide syringes had the following problems. Safety mechanism - failure (6). Needle clogged/blocked (13). Leakage (10). Scale marking missing (5). Needle and syringe separate / spin out (3). Needle stick (13). The following was reported by the initial reporter: "it was reported via survey response that the clinician experienced needlestick injury after patient use prior to safety mechanism activation (7), needlestick injury after patient use after safety mechanism activation (locked over needle) (6), needle clogged (10), unable to inject medications (3), needle detaches from syringe (3), scale marking missing/illegible (5), needle pulled out of hub (2), leakage (10), safety system doesn't trigger (6), needle bends (8). Additional information related to what leaked and from where states: "medication" "the syringe" additional information to nsi prior to safety activation states: "it didn¿t close properly. " additional information to nsi after safety activation states: "no further information to add". Additional information related to impact of safety system doesn't trigger states: "a puncture. " additional information related to impact of needle bends states: "a puncture. ". ".
 
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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 Key11625479
MDR Text Key253055156
Report Number2243072-2021-00969
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
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 Received04/06/2021
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: 04/06/2021 Patient Sequence Number: 1
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