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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE PMCF PISTON SYRINGE

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BECTON DICKINSON SYRINGE PMCF PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Volume Accuracy Problem (1675); Inappropriate Audible Prompt/Feedback (2280); Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2021
Event Type  malfunction  
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: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. (b)(4).
 
Event Description
It was reported that up to 22 syringe pmcf had one or more of the following issues before or during use. Scale marking issues (10), plunger rod damaged (5), syringe pump alarms during syringe use (2), drug potency issue (5) the following was reported by the initial reporter: "it was reported via survey response that the clinician encountered drug potency issue, scale marking issue (e. G. Missing/misprinted/blurred scale markings), plunger rod broken/damaged, syringe malfunctioned/caused occlusion alarm while on a pump, difficulty drawing fluid/medication into syringe related to luer lok and luer slip tip syringes. ".
 
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Brand NameSYRINGE PMCF
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11316625
MDR Text Key265897099
Report Number2243072-2021-00315
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,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
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 Received01/14/2021
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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