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

Model Number 8881511110

Device Problem Fail-Safe Problem (2936)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 08/26/2020

Event Type  Injury  

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 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10485559
• MDR Text Key: 205455223
• Report Number: 1915484-2020-01189
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: 20884521014937
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511110
• Device Catalogue Number: 8881511110
• Device Lot Number: 009713X
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other