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

Model Number 8881850510

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/23/2018.The incident sample has been requested but to date has not been received 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 reported foreign debris on the needle.

Manufacturer Narrative

A review of the device history record (dhr) for shop order 1206791 that there were no defects found in 222 visual samples inspected from the shop order.There were no non-conformance reports (ncr)¿s issued to the lot.There were no samples submitted with this complaint for lot # 633634.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.The customer returned sample from a different lot number for the same reported condition and the defect of string flash was identified and confirmed.The most likely root cause was due 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.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 foreign matter and molding flash.The lot met the acceptance criteria and was released.An issue impact assessment (as known as a health hazard evaluation or health hazard assessment) was conducted for magellan gate.The assessment discusses a potential hazard scenario where the plastic fibers are injected into a patient and assesses the risks associates with such an event.The likelihood of occurrence was considered ¿rare¿, the probability of injury occurring was considered ¿unlikely but possible¿, and the severity of the injury was considered ¿severe¿.The overall risk score was ¿low¿ for that assessment.Based on the low risk associated with the issue, no corrective action will be taken at this time.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: 7293926
• MDR Text Key: 100901123
• Report Number: 1017768-2018-00011
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 20884521000565
• UDI-Public: 20884521000565
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 633634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: No
• 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