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

Model Number 1180300555

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

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 Description

The customer reported that there were scratches and holes in the syringe that make blood bubble when they pull it.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9251544
• MDR Text Key: 164433482
• Report Number: 1017768-2019-00715
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012295
• UDI-Public: 10884521012295
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 1180300555
• Device Catalogue Number: 1180300555
• Device Lot Number: 833204
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 02/14/2020
• Patient Sequence Number: 1