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

Model Number	8881511110
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	08/26/2020
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.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 reports that during an insulin injection, they got a dirty needle stick because the safety shield on the device did not lock into place.

• 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: 10485559
• Report Number: 1915484-2020-01189
• Device Sequence Number: 19502097
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: 20884521014937
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 8881511110
• Device Catalogue Number: 8881511110
• Device Lot Number: 009713X
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other