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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PMCF-SAFETYGLIDE-SYRINGE

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BECTON DICKINSON UNSPECIFIED BD PMCF-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
Date of event: unknown. The date received by manufacturer has been used for this field. "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. " 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 unspecified bd¿ pmcf-safetyglide-syringe had a needlestick injury on 30 occasions, was unable to inject medication on 50 occasions, the needle detached from the syringe on 10 occasions, the needle was dull/blunt, the needle pulled out of the hub on 30 occasions, leaked on 2 occasions, and the needle was bent on 2 occasions. The following information was provided by the initial reporter: material no: unknown batch no: unknown. It was reported via survey response that the clinicians experienced needlestick injury after patient use prior to safety mechanism activation (30), unable to inject medications (50), needle detaches from syringe (10), needle dull/blunt (1), needle pulled out of hub (30), leakage (2), needle bent (2) additional information related to needle stick after use states: "the protection mechanism didn't work" additional information related to needle stick prior to use states: "because of a problem with the needle which became detached" additional information related to needle detaches from syringe states: "because the marking was illegible, it was thrown additional information related to needles broken states: "found broken in several places".
 
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Brand NameUNSPECIFIED BD PMCF-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 Key11627111
MDR Text Key255137332
Report Number2243072-2021-00978
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 07/27/2021
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 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 Received07/27/2021
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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