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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE PLUS X100L PNG CLEAR SYRINGE

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BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE PLUS X100L PNG CLEAR SYRINGE Back to Search Results
Catalog Number 47451130
Device Problems Fluid Leak (1250); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that before use of the ultrasafe plus x100l png clear there was an issue with leakage. The cap was difficult to remove and when removed the product ran out of the cannula with out the piston being pushed. The following information was provided by the initial reporter: patient returned 1¨prolia syringe to the pharmacy: needle safety cap hardly removable, could only be removed with huge power, when cap was removed, product ran out via the cannula. According to the pharmacist, the patient did not touch the piston while trying to remove the needle safety cap. No application possible.
 
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Brand NameULTRASAFE PLUS X100L PNG CLEAR
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU 2851
Manufacturer (Section G)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU 2851
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9377480
MDR Text Key219387156
Report Number3009081593-2019-00267
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number47451130
Device Lot Number9136532
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2019
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: 11/26/2019 Patient Sequence Number: 1
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