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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. DISCARDIT II¿ SYRINGE W/NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 300330
Device Problems Crack (1135); Physical Resistance (2578); Aspiration Issue (2883)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the discard it ii¿ syringe w/needle has difficulty drawing up medicine, the barrel of the syringe is cracked, once the drug is withdrawn, it is difficult to push, and drawing of blood needs to done with force which leads to hemolysis. Found during use. No reports of serious injury or medical intervention noted.
 
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Brand NameDISCARDIT II¿ SYRINGE W/NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
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
8015652845
MDR Report Key7614678
MDR Text Key112310894
Report Number3002682307-2018-00149
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300330
Device Lot Number1701193
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2017
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: 06/19/2018 Patient Sequence Number: 1
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