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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1CC SAF SYR E100 29X1/2 SYRINGE, PISTON

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COVIDIEN 1CC SAF SYR E100 29X1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881511110
Device Problem Fail-Safe Problem (2936)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 08/26/2020
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 reports that during an insulin injection, they got a dirty needle stick because the safety shield on the device did not lock into place.
 
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Brand Name1CC SAF SYR E100 29X1/2
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 Key10485559
MDR Text Key205455223
Report Number1915484-2020-01189
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,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511110
Device Catalogue Number8881511110
Device Lot Number009713X
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/02/2020 Patient Sequence Number: 1
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