MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE 22G X 1 RP; SYRINGE, PISTON

Model Number	8881513231
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
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 the clinic said some of the markings are missing or very light.
Additional Manufacturer Narrative
A review of the device history record found no manufacturing or inspection anomalies indicative of syringe issue.There were no samples returned with this complaint, however a photograph was submitted showing a syringe in an opened state with what seems to be partial printed graduation lines near the three ml end; the reported condition is confirmed.As the syringe could not be physically inspected the root cause could not be determined.The most likely cause of this type of condition is a tape fold over which is the only condition that can be self- corrected.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are visually inspected for damaged and missing components.The lot met all defined acceptance requirements and was released.After reviewing the complaint, it did not identify any indication of a systemic issue with the product or process, so a formal corrective/preventative action (capa) will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SYRINGE 22G X 1 RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9098621
• Report Number: 1017768-2019-00686
• Device Sequence Number: 2752646
• Product Code: FMF
• UDI-Device Identifier: 20884521012711
• UDI-Public: 20884521012711
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 8881513231
• Device Catalogue Number: 8881513231
• Device Lot Number: 909142
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1