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

Model Number	1180300555
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
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 there were scratches and holes in the syringe that make blood bubble when they pull it.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot number was performed.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.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, the lot met all defined acceptance requirements and was released.There were 246 samples and two pictures were received for the evaluation.Upon visual examination of the sample, the reported condition is confirmed.The most likely root cause is misalignment at the horizontal orientation wheel/screw apparatus.This is supported by the symmetrical damage on the barrel which are the approximate contact points of the screw.The investigation did not identify a systemic issue with the product or process.Therefore, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SYRINGE REGULAR LUER TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9251544
• Report Number: 1017768-2019-00715
• Device Sequence Number: 2031120
• Product Code: FMF
• UDI-Device Identifier: 10884521012295
• UDI-Public: 10884521012295
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 1180300555
• Device Catalogue Number: 1180300555
• Device Lot Number: 833204
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1