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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the slide safety feature on this insulin syringe does not stay in place.It can be easily retracted.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and shows that all acceptance criteria inspections were within acceptable limits during the production process.One unpackaged sample with this customer report.A complete investigation was performed.Visually, there was nothing observed that was out of the ordinary.Testing was conducting for shield extension, shield retraction, shield locking torque, and shield collar/spin.These tests were selected as they would best examine whether the safety mechanism of the syringe worked properly.All test results met the specification requirements.The plastic shield on the safety syringe is designed to slide forward to cover the needle to prevent needle sticks and the safety mechanism will deactivate if you do not pull the shield up all the way and twist it.Based on the description provided by the customer they may not have fully activated the safety mechanism.We will continue to trend this issue for future occurrences as part of the complaint review process and to assess the need to initial a formal corrective/preventative action.

• 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: 11709395
• Report Number: 1915484-2021-01236
• Device Sequence Number: 17143578
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1