MAUDE Adverse Event Report: COVIDIEN MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850110
Medical Device Problem Code	Shielding Failure (1568)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 12/26/2017.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that a nurse sustained a needle stick with product which failed to lock after safety needle cover was advanced over the needle.
Additional Manufacturer Narrative
The device history record (dhr) for lot 724914 indicates that there were zero defects found in 544 visual samples and zero defects found in 694 physical samples inspected from the lot.There were no non-conformance reports (ncr)s issued to this lot.There were no samples submitted with this complaint.The reported condition could not be confirmed without an actual sample to evaluate.The exact root cause could not be determined based on the available information.There were no samples returned with this complaint, so the reported condition could not be confirmed.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, samples are inspected for shield stalling/lock failure.The product met all defined acceptance requirements and was released.Based on the investigation and root cause analysis, the initiation of a corrective/preventative action (capa) is not required.The complaint was not confirmed and the potential root cause identified during the investigation based on the limited information was related to the user error.It¿s recommended the user consult the instructions for use included with the product for guidance.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 7145586
• Report Number: 1017768-2017-05181
• Device Sequence Number: 16378711
• Product Code: FMI
• UDI-Device Identifier: 20884521000510
• UDI-Public: 20884521000510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 8881850110
• Device Catalogue Number: 8881850110
• Device Lot Number: 724914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1