MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881535762
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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.
Event or Problem Description
The customer reported that the markings on the syringe are wrong and potentially resulting in a draw up of more fluid than needed.There was no patient harm reported.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) review could not be performed because the lot number is unknown.The manufacturing site received two unsealed package samples with this customer report.A complete investigation was performed.Visual inspection to the quality inspection standard (qis) was conducted.Low top line was identified on one of the syringe samples received.On the syringe identified with a low top line, there was also damage to the barrel thumb rest.The second sample had zero issues.The most probable root cause for the low top line barrel print is a result of the damage to the base of the barrel.It is likely the barrel was not able to be fully seated properly on the pin at the barrel print station causing the print to be applied lower on the barrel.The most probable root cause for the damaged barrel is the part being caught during transfer within the assembly process.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 qiss during the syringe assembly processes.The manufacturing site maintains a 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 qis.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 the manufacturing, process inspectors inspect product at periodic intervals to ensure it meets acceptable quality limits (aql).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 qis and the statistical sampling must meet the aql requirements during the molding and assembly process.Operators are instructed to inspect all product used for regrinding 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.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.A quality alert will be distributed to necessary production and quality personnel to heighten awareness to the confirmed reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: 35ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 12094724
• Report Number: 1915484-2021-01260
• Device Sequence Number: 14499968
• Product Code: FMF
• UDI-Device Identifier: 20884521012193
• UDI-Public: 20884521012193
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/13/2021

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: 8881535762
• Device Catalogue Number: 8881535762
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1