MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881513934
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 plunger not sealing into the syringe.
Additional Manufacturer Narrative
A review of the device history record found no manufacturing or inspection anomalies indicative of a syringe deficiency.A video was submitted with the complaint.The video exhibited that the plunger tip was separated.The complaint report was confirmed.The root cause of this type of condition is a failure in orientation of the plunger when inserted into the barrel due to misalignment or double loading.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 damage and missing components.The lot met all defined acceptance requirements and was released.A review of complaints and subsequent defects did not identify any indication of a systemic issue with the product or process, so a 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 LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9397706
• Report Number: 1017768-2019-00744
• Device Sequence Number: 11296028
• Product Code: FMF
• UDI-Device Identifier: 20884521012858
• UDI-Public: 20884521012858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/25/2020

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: 8881513934
• Device Catalogue Number: 8881513934
• Device Lot Number: 826805
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1