MAUDE Adverse Event Report: COVIDIEN 3/10CC INS SAFETY SYR 30X5/16; SYRINGE, PISTON

Model Number	8881511344
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 reported that he had a faulty insulin syringe where the mechanism would not lock after he used the syringe.He tried multiple times but the locking mechanism would not engage.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site has not received any samples or photos for evaluation.Therefore, the reported issue could not be confirmed.Without a representative sample(s) or picture(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without a sample or picture, a more definitive root cause cannot be determined at this time.During the assembly of this product, inspectors routinely test samples for visual defects, shield retract force, shield extend force, shield-locking torque, shield/collar spin force, and detach force.The test results are reviewed for each shop order prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.The plastic shield on the safety syringe is designed to slide forward to cover the needle to prevent needle sticks after use.The safety mechanisms will deactivate if you do not pull the shield all the way up and twist it.The instructions for use of the safety syringe are on the back of each unit box which state, ¿immediately following injection, extend shield forward fully until click is heard.Then lock safety shield by twisting in either direction until you feel the positive stop and hear the audible snap.¿ material verification processes are in place.The cannula must pass an inspection and certification review before they are released to the floor for production.All lots of hypodermic needle tubing meet the requirements defined in international standard iso 9626 stainless steel needle tubing for manufacture of medical devices.Based on the information available and the investigation findings, formal corrective/preventative actions are not deemed necessary at this time.
Additional Manufacturer Narrative
The item code originally reported by the customer was incorrect.The following sections have been updated: section d1 - brand name.Section d4 - model number, catalog number, udi number.

• Brand Name: 3/10CC INS SAFETY SYR 30X5/16
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9774761
• Report Number: 1915484-2020-01138
• Device Sequence Number: 11334933
• Product Code: FMF
• UDI-Device Identifier: 20884521014999
• UDI-Public: 20884521014999
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/12/2020

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: 8881511344
• Device Catalogue Number: 8881511344
• Device Lot Number: 927409X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 02/12/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/08/2020; 05/12/2020
• Patient Sequence Number: 1