MAUDE Adverse Event Report: COVIDIEN 23GX1" NS BULK MAGELLAN SAFE NEEDLE X2K; SAFETY NEEDLE

Model Number	7777850310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way.Upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a safety needle.Customer reports: the nurse noticed that the needle was broken (blue needle hub) before injection.The hub assembly and needle disconnected from the syringe.There was no harm to the patient reported.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no issues identified with the operation of the equipment during the review.There were 2 samples (1 opened, 1 unopened (customer's packaging)) submitted with this complaint.The opened sample was cracked at the luer of the hub and the lugs of the hub were damaged from what appeared to be forcible attachment of the device.The unopened sample had no signs of damaged.The reported condition is confirmed.The exact root cause could not be determined based on available information.Prior to a lots 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 inspected for hub leaks and damage.The lots met all defined acceptance criteria and were released.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.The investigation did not identify a systemic issue with the product or process.It is recommended the user consults the instructions for use for guidance when attaching the device.

• Brand Name: 23GX1" NS BULK MAGELLAN SAFE NEEDLE X2K
• Common Device Name: SAFETY NEEDLE
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• MDR Report Key: 6159727
• Report Number: 1017768-2016-00136
• Device Sequence Number: 16366528
• Product Code: FMI
• UDI-Device Identifier: 05907527942002
• UDI-Public: (01)05907527942002
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/28/2016

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: Health Professional
• Device Model Number: 7777850310
• Device Catalogue Number: 7777850310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 03/08/2017
• Patient Sequence Number: 1