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U.S. Department of Health and Human Services

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

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COVIDIEN 1/2CC E100 SAF 29X1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881511136
Device Problem Fail-Safe Problem (2936)
Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
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.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event Description
Customer reports: after administration of insulin when the nurse tried to engage the safety shield, it didn't lock into place correctly.
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Brand Name1/2CC E100 SAF 29X1/2
Manufacturer (Section D)
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
MDR Report Key11626928
MDR Text Key244168440
Report Number1915484-2021-01224
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
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511136
Device Catalogue Number8881511136
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/07/2021 Patient Sequence Number: 1