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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE 22X1 LL ECLIPSE ANESTHESIA SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE 22X1 LL ECLIPSE ANESTHESIA SYRINGE Back to Search Results
Catalog Number 30281864
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone number: (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 needle 22x1 ll eclipse safety shield failed and detached. The following information was provided by the initial reporter: "after administered the medicine to 2 patients by different professionals with the needle, the safety shield released. Info add received: no damage. No needle stick. Confirmed that when trying to activate the safety mechanism the safety shield released from the material. No photos available. ".
 
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Brand NameNEEDLE 22X1 LL ECLIPSE
Type of DeviceANESTHESIA SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key10089342
MDR Text Key199525766
Report Number3003916417-2020-00151
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number30281864
Device Lot Number9197534
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2019
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: 05/26/2020 Patient Sequence Number: 1
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