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

Model Number	8881850815
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported single needle found to be contaminated with small black particles when removed from packaging.The product was not used on a patient.
Additional Manufacturer Narrative
A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.There was one sample (opened) returned with this complaint.A visual inspection of the sample confirmed the presence of inclusions in the molded plastic sheath of the sample.The reported condition of contamination is not confirmed, because the inclusions are parental material to the injection molding process.The exact root cause of the reported condition could not be determined based on available information.However, based on available information and the results of the sample evaluation, the most probable root cause was identified as burnt resin that broke loose from the inside of the barrel of the injection molding machine and became embedded in the plastic (inclusions).The reported condition presents no risk to the patient, because the specks were embedded in the plastic sheath, which is discarded prior to use.No other complaints have been received for this lot and there were no manufacturing or inspection anomalies found during the investigation.The available information indicates the condition was most likely a result of an isolated event, so a corrective/preventative action (capa) is not necessary.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: 6610870
• Report Number: 1017768-2017-05070
• Device Sequence Number: 7409
• Product Code: FMI
• UDI-Device Identifier: 10884521000605
• UDI-Public: 10884521000605
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: Other
• Device Expiration Date: 06/01/2020
• Device Model Number: 8881850815
• Device Catalogue Number: 8881850815
• Device Lot Number: 521563X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1