MAUDE Adverse Event Report: 35ML SYR REGULAR LUER 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	06/23/2021
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.  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 their staff found inaccurate markings on 35 ml syringe.Per customer, it looks like the stamp was lined up incorrectly with the bottom of the plunger instead of at the top and this is an issue with being unable to measure medications accurately.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record for lot 108930x was reviewed.The product was manufactured and packaged between march 24-25, 2021.During the manufacturing of the syringe assemblies, a sampling was visually inspected and physically tested with 0 issues recorded relating to this report.During the printing process, a sampling of barrels was visually inspected with 0 issues recorded relating to this report.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 report.A physical sample was not received for the investigation.However, two photos were provided.The photos were reviewed.In both photographs, one 35 ml monoject syringe can be observed with the identifying cap print indicating that the syringe is from lot 108930x.One photograph shows the plunger fully inserted and one photograph shows the plunger slightly drawn back.In both photographs, the 0 ml graduation is observed to be significantly low which would cause the volumetric measurements to be incorrect.The condition of an incorrectly printed low top graduation line can result if a single syringe barrel is not fully seated on the printer pin prior to printing.One potential cause for a barrel not being fully seated on the printer pin can be due to a misalignment of the push-on tool due to typical vibrations at the barrel printer station.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.In addition, a quality alert will be distributed to all necessary production and quality personnel to heighten awareness of the reported condition.No further corrective actions are applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Section d4 has been updated to display the correct item code (8881535762) and udi ((b)(4)).
Additional Manufacturer Narrative
Complaint trending was reviewed for item code 8881535762 and a capa (corrective and preventive action) was assigned as a result.This action is designed to prevent the reoccurrence of the reported and confirmed condition.

• Brand Name: 35ML SYR REGULAR LUER TIP RP
• Common Device Name: SYRINGE, PISTON
• MDR Report Key: 12067180
• Report Number: 1915484-2021-01259
• Device Sequence Number: 4765713
• Product Code: FMF
• UDI-Device Identifier: 20884521012223
• UDI-Public: 20884521012223
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 11/02/2021

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
• Device Lot Number: 108930X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 06/24/2021; 06/24/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 09/01/2021; 10/25/2021; 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1