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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. DISCARDIT¿ II SYRINGE W/O NEEDLE

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BECTON DICKINSON, S.A. DISCARDIT¿ II SYRINGE W/O NEEDLE Back to Search Results
Catalog Number 300296
Device Problem Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 discardit¿ ii syringe w/o needle after separating the plunger from the syringe we realize that there is plastic residues inside the barrel of the syringe. Foreign complaint the following information was provided by the initial reporter, translated from to (b)(6) to english: after separating the plunger from the syringe we stopped with fm (plastic?) particles inside the barrel.
 
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Brand NameDISCARDIT¿ II SYRINGE W/O NEEDLE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8473905
MDR Text Key145093134
Report Number3002682307-2019-00221
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300296
Device Lot Number1806112
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 Received03/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2018
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: 04/02/2019 Patient Sequence Number: 1
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