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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LL 21GA 1IN TW PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LL 21GA 1IN TW PISTON SYRINGE Back to Search Results
Catalog Number 302171
Device Problem Packaging Problem (3007)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringes 10 ml ll 21ga 1 in tw had a damaged package that compromised sterility. The following information was provided by the initial reporter: "uncupped needle that caused needle stick to the staff".
 
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Brand NameSYRINGE 10ML LL 21GA 1IN TW
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12392733
MDR Text Key268988894
Report Number8041187-2021-00786
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
NA
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
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302171
Device Lot Number0052860
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 Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2020
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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