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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML 21G 1-1/4IN PISTON SYRINGE

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BECTON DICKINSON SYRINGE 10ML 21G 1-1/4IN PISTON SYRINGE Back to Search Results
Catalog Number 59006488
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. 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. Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Date of event: unknown. The date received by manufacturer has been used as a default.
 
Event Description
It was reported that syringe 10ml 21g 1-1/4in contained foreign matter. The following information was provided by the initial reporter: "foreign material in needle hub".
 
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Brand NameSYRINGE 10ML 21G 1-1/4IN
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12601852
MDR Text Key276192086
Report Number2243072-2021-02473
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number59006488
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
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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