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

Model Number	8881892950
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that the safety lock did not engage correctly and the nurse was stuck by the needle.The rn went to emergency department for testing.
Event or Problem Description
The customer reported that the safety lock did not engage correctly and the nurse was stuck by the needle.The rn went to ed for testing.Additional information received stated the needle stick occurred when the nurse was disposing of the needle after giving an insulin injection.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information provided by the customer.

• Brand Name: MAGELL INSULIN 1/2ML 29GX1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11051266
• Report Number: 1915484-2020-01201
• Device Sequence Number: 14124174
• Product Code: FMF
• UDI-Device Identifier: 10884521005945
• UDI-Public: 10884521005945
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881892950
• Device Catalogue Number: 8881892950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other