MAUDE Adverse Event Report: COVIDIEN ATNAA ROUND FERRULE NDL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 7070005

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported possible lot numbers 800865 and 805037.The device history records were reviewed and indicated that the products were released accomplishing all quality standards.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.Process monitoring data for the lots was reviewed and there were no issues.A review of the machine setup was conducted and there were no issues.The jars used to pack the product were reviewed and no particulate or flash was seen.Samples were not received for the investigation; however, there was one photo returned with this complaint.A review of the photo and lab report were completed.Based on the photo and lab report the particulate appears to have been generated from the plastic jar.The reported condition is confirmed.The most likely root cause of the particulate is that it came from the top of the jar.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, product is checked for foreign material during the production and packaging processes.The lot met all defined acceptance requirements and was released.A note was added to the formula sheet to check the jar for contamination and flash.A note to the formula sheet to check the jar for contamination and flash.This information will be utilized for trending purposes to determine the need for additional corrective actions.

Event Description

The customer reports during an inspector observed a piece of clear particulate inside the needle bowl.Possible lot numbers 800865 and 805037.Since the customer combines component lots, they are unable to specify the source lot in question.

Manufacturer Narrative

The product involved is an oem unsterile cannula.After further review it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.No additional follow ups or investigation results will be sent.

• Brand Name: ATNAA ROUND FERRULE NDL
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8113163
• MDR Text Key: 128914957
• Report Number: 1017768-2018-00525
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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: 7070005
• Device Catalogue Number: 7070005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1