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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELL INSULIN 1/2ML 29GX1/2 SYRINGE, PISTON

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COVIDIEN MAGELL INSULIN 1/2ML 29GX1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881892950
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/20/2020
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported, after giving an insulin injection, the nurse pushed up on the safety shield to activate it and the needle bent at about a 90 degree angle and punctured through the safety cap stabbing the nurse's index finger. A bandage was placed on the finger and no further testing was done.
 
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Brand NameMAGELL INSULIN 1/2ML 29GX1/2
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10474084
MDR Text Key205084387
Report Number1915484-2020-01188
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881892950
Device Catalogue Number8881892950
Device Lot Number013974X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/31/2020 Patient Sequence Number: 1
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