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 Code	Needle Stick/Puncture (2462)
Date of Event	03/12/2021
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 after medication delivery, when the safety latch was extended forward, the nurse proceeded to place the needle into the sharps box vertically with the needle facing up, the wings down by the plunger caught the edge of the sharps container as the nurse pushed the syringe into the sharp container, the safety glide, slide down enough to cause a needle puncture.The customer could not verify if an audible click heard after activation.The sharps container was not full, only had a fill items in it and it was a large container.The customer further confirmed, the needle was contaminated.The nurse washed her hands, lab tests were performed and had medical visits to go over the results.The lab test results were negative for both source patient and the nurse.

• 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: 11698450
• Report Number: 1915484-2021-01234
• Device Sequence Number: 3535676
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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
• Device Lot Number: 030738X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other