MAUDE Adverse Event Report: COVIDIEN MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881892910
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The manufacturing site received twenty-two (22) samples for evaluation.A complete investigation was performed and a visual inspection to the quality inspection standard was conducted.Twenty-two (22) samples were found to contain the defect of ¿graduation printing: non-printing or illegible of two (2) or more graduations and/or numerals¿.The most probable root cause for the missing print is due to a part jam on the continuous motion machine (cmm) within the assembly process.It is likely a jam occurred after the barrel print was applied causing portions of the ink to be rubbed off before continuing to proceed along the assembly process.Adjustments to the timing of the conveyor line is made at each start up and after changing the print pad.The barrel printer automatically scraps start up production until the process is accepted to be stable.Evaluation of print adhesion is conducted with a tape test and the ink viscosity is controlled and verified to be within a validated viscosity range.Associates are required to verify the barrel print meets the requirements per the quality inspection standard before any product is accepted into production at start up and at prescribed intervals throughout the length of the production run.The following control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.The manufacturing site maintains material verification processes.The raw materials must pass an inspection and certification review before release to the floor for production.The manufacture of all molded components is conducted within a validated process inside a controlled manufacturing area.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications, and are visually and physically tested for adherence to the quality inspection standard.If problems were detected during processing, non-conforming product would be identified and segregated.Molding, printing, assembly, and packaging machine maintenance requirements are documented.Records of maintenance activities are maintained.Personnel are trained and certified in the operation of the molding, printing, assembly, and packaging equipment.Personnel are trained and certified in the process of product evaluation and documentation requirements.During manufacturing, process inspectors inspect product at periodic intervals to ensure it meets acceptable quality limits.Process inspectors are required to conduct visual and physical evaluations at prescribed intervals and cannot release product unless the required aql has been met per the specification.Procedures and standard work instructions exist for the set-up, operation, and maintenance of the molding machines and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.Various validated detection units such as a rubber tip detection unit, plunger detection unit, barrel blow-out probe, and print tape break detectors are in place and verified at prescribed intervals to verify functionality.All lots and shop orders are visually and physically inspected to the quality inspection standard and the statistical sampling must meet the acceptable quality limit requirements during the molding and assembly process.Operators are instructed to inspect all product used for regrind activities for potential contaminants such as color, rubber tips, cannula, or inclusions to assure it is clean before regrinding.A lot cannot be released unless it passes specification requirements.This syringe is intended to be a single use syringe and not qualified as a prefill syringe.
Event or Problem Description
The customer reported a print issue.Upon investigation on 03-dec-2019, twenty-two (22) samples were found to have two or more non printed or illegible graduations and or numerals.

• Brand Name: MAGELLAN INSULIN 1ML 29GX1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9438496
• Report Number: 1915484-2019-01106
• Device Sequence Number: 4202146
• Product Code: FMI
• UDI-Device Identifier: 10884521005938
• UDI-Public: 10884521005938
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: 8881892910
• Device Catalogue Number: 8881892910
• Device Lot Number: 827121X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1