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

Model Number 8881850015

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/22/2018.The incident sample has been requested but to date has not been received at the manufacturing site for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that there are small impurities on the needle due to plastic particles.

Manufacturer Narrative

Submission date: 08/17/2018.An investigation was performed for the reported customer complaint: ¿the customer reports that there are small impurities on the needle due to plastic particles.¿ a review of the device history record (dhr) for reported lot number 610284 indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.During the manufacturing of the syringe assemblies, syringes were visually inspected and physically tested.No deficiencies were recorded relating to this customer report.Control mechanisms are in place to prevent the occurrence and acceptance of damaged syringes during the syringe molding, assembly and packaging processes.These mechanisms include, but are not limited to: material verification/certification processes, periodic audits, dimensional specifications, machine maintenance requirements, and personnel training and certification.The syringe barrel is visually inspected periodically during the production process to the visual standards defined by the classification of defects in the quality inspection standard.A lot cannot be released unless it passes all visual and physical testing requirements.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.Inspections focus on damaged product or components, holes, splits, or cracks in barrel which permit leakage, leakage in fluid pathway, and luer tip not to specification.Testing for this component during production includes the plunger being exercised during the assembly process to distribute the silicone in the barrel and on the rubber tip.Leak testing is also conducted to ensure the syringe draws, holds and expels fluid properly.There were no non-confirming records (ncrs) issued for this reported lot.The actual device was not returned for evaluation.Two (2) samples, (1 opened, 1 unopened), were provided from the customer.A photograph was also provided.All samples were visually inspected for foreign debris and string flash.There were no observations of foreign debris or string flash on the unopened sample, but there was string flash extending from the gate of the safety shield and wrapping around the needle of the opened sample.A probable cause could be attributed to flash, which is stringy plastic material attached at the molded part's gate (the entrance to the mold cavity) forming when melted plastic resin remains at the injection gate as the two mold halves separate.An issue impact assessment (as known as a health hazard evaluation or health hazard assessment) was conducted for magellan gate strings.The assessment explores potential hazard scenarios where the plastic fibers are injected into a patient and assesses the risks associated with such an event.The overall risk score was ¿low¿ for that assessment.Based on the low risk associated with the issue, no additional corrective action will be taken at this time.The reported condition is confirmed.The root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• Manufacturer (Section G): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7534218
• MDR Text Key: 108982501
• Report Number: 1017768-2018-00044
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 20884521000497
• UDI-Public: 20884521000497
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 8881850015
• Device Catalogue Number: 8881850015
• Device Lot Number: 610284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1