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 04/04/2018

Event Type  malfunction  

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 Description

The customer reports during manual visual inspection an inspector found foreign material on the cannula of the product.Possible lot 728235 or 728236.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: 8113310
• MDR Text Key: 128744695
• Report Number: 1017768-2018-00526
• 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: 09/20/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• 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