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

Model Number	8881511235
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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 or Problem Description
The customer reported that there was a needle stick injury with a monoject insulin syringe.The nurse attempted to push the safety shield up over the used needle with their left index finger and the safety shield did not move freely.It was stuck and seemed like it was locked in the original position.A click was not heard and the shield did not extend forward as the safety shield was not able to be activated.The nurse had to go to occupational health to get a tetanus vaccine.Blood was not drawn and there was no further medical intervention.The nurse followed policy and procedure for employee needle sticks at lumc.Source testing was sent on the patient after the needle stick and all results came back negative.At this time no follow up testing or medical intervention is required as all testing results were negative per occupational health.
Additional Manufacturer Narrative
Section d4 has been updated to reflect the below corrected information provided by our customer.Model number: 8881511235, catalog number: 8881511235, lot number: 004868x, udi: (b)(4).

• Brand Name: 1CC SAF SYR E100 29X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10165125
• Report Number: 1915484-2020-01171
• Device Sequence Number: 3083597
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: 20884521014937
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 8881511235
• Device Catalogue Number: 8881511235
• Device Lot Number: 004868X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other