MAUDE Adverse Event Report: COVIDIEN 20 ML SYRINGE,ECCENTRIC TIP; SYRINGE, PISTON

Model Number	8881520665
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2020
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 that the luer tip of the syringe broke off prior to use.
Additional Manufacturer Narrative
The item code originally reported by the customer was incorrect.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device history record for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.Two decontaminated samples were received at the manufacturing site for evaluation.Both syringe samples were received in the sleeve.Visual inspection to the quality inspection standard was performed and the reported condition was confirmed, a broken luer tip was identified on both of the syringe samples.There was no other apparent machine damage to the plunger, rubber tip, or sleeve components.The plastic buildup seen on the outside diameter of both sleeves, is evidence of an adequate transfer of plastic from cap to sleeve, during the heat staking process.A root cause analysis indicated that the failure is confirmed to be associated with manufacturing.The following potential root causes have been identified: if the barrel transfer lines to the assembly machine from the printer are empty and the air in the lines is up too high, the barrels potentially could hit together too hard and damage or break the tips, when the first two barrels come into the line.The barrels may have gotten damaged during the printing process, or orientation on the printing process, however a sensor checks every printed barrel for a broken taper right after printing and diverts any missing or broken tips to scrap.On 7/21/2020, qe went to process and verified with ff sme¿s this sensor is functioning correctly.It is possible an operator missed removal of a damaged part following a jam in the dials in the 20ml kahle, during the syringe assembly process.Because production associates are trained on any equipment they run, it possibly occurred without causing the machine to alarm or shut off, and therefore may have gone undetected.The following process controls are in place: 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, printed, assembled, and packaged product 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 which 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.Mold tool and mold machine maintenance requirements are documented.Records of maintenance activities are maintained.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, product evaluation and documentation requirements.During manufacturing, associates inspect product at periodic intervals to ensure it meets acceptable quality levels.The plunger is exercised during the assembly process to redistribute the silicone in the barrel and on the rubber tip.Leak testing is conducted to ensure the syringe draws, holds.And expels fluid properly.Periodic audits are conducted to ensure the quantity of barrel inner dimension silicone lubricant is within specification 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.All lots and shop orders are visually and physically inspected to the quality inspection standard, and the statistical sampling must meet the acceptance quality level requirements during the molding and assembly process.A lot cannot be released unless it passes specification requirements.At this time, the criteria for a formal investigation has not been met, and a corrective and preventative action will not be initiated.Per procedure, complaint trends are evaluated during the monthly capa meeting to determine if a capa is warranted.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 20 ML SYRINGE,ECCENTRIC TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9741620
• Report Number: 1915484-2020-01136
• Device Sequence Number: 19283213
• Product Code: FMF
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2020

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: 8881520665
• Device Catalogue Number: 8881520665
• Device Lot Number: 911279X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 02/11/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/30/2020; 07/22/2020
• Patient Sequence Number: 1