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

Model Number 8881511235

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

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 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.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10165125
• MDR Text Key: 195476237
• Report Number: 1915484-2020-01171
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: 20884521014937
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511235
• Device Catalogue Number: 8881511235
• Device Lot Number: 004868X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other