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

Model Number	8881511136
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
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
Customer reports: after administration of insulin when the nurse tried to engage the safety shield, it didn't lock into place correctly.
Additional Manufacturer Narrative
Additional information was received on 4/8/21 therefore the following updates have been added to the 3500a form.B2: the nurse received a needle stick from a contaminated needle.H1: updated to include serious injury.H6: updated health effect clinical code.Updated health effect impact code.
Event or Problem Description
The nurse received a needle stick from a contaminated needle.

• Brand Name: 1/2CC E100 SAF 29X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11626928
• Report Number: 1915484-2021-01224
• Device Sequence Number: 3496636
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 8881511136
• Device Catalogue Number: 8881511136
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other