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

Model Number	8881850110
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 9/15/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that air is being drawn into the syringe whilst obtaining samples.
Additional Manufacturer Narrative
The device history record (dhr) for lot 635759 indicates that there were zero defects found in 544 visual samples and zero defects found in 694 physical samples inspected from the lot.A review of the entire dhr did not identify any manufacturing or inspection anomalies.There were no samples returned with this complaint, but there were samples returned from a related complaint by the same customer.All samples were unopened upon receipt.The needles were evaluated for potentially related defects and no issues were observed.The syringe barrels returned with the similar complaint was not manufactured by medtronic.Those syringes were inspected for damage (cracks, holes and splits) and luer taper, but zero defects were identified.The reported condition could not be confirmed.The exact root cause could not be determined based on available information.A 6m root cause investigation was conducted and reviewed multiple potential contributing factors.The most likely root cause was potentially due to improper assembly by the user.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 luer taper, hub leakage and damage.The lot met all defined acceptance criteria and was released.The investigation did not identify a systemic issue with the product or process.The investigation identified a most probable root cause that was unrelated to the manufacture of the safety needle.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.It¿s recommended the user consults the instructions for use for guidance when attaching the device.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: 6870199
• Report Number: 1017768-2017-05140
• Device Sequence Number: 898666
• Product Code: FMI
• UDI-Device Identifier: 20884521000510
• UDI-Public: 20884521000510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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 Model Number: 8881850110
• Device Catalogue Number: 8881850110
• Device Lot Number: 635759
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 02/13/2018
• Patient Sequence Number: 1