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 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/12/2018.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 states: metal shavings on the needle.No patient involved.Additional information from the customer states that the metal shavings were in the wrapping and on the needle.

Manufacturer Narrative

Submitted 12/28/2018.An investigation was performed for the reported customer complaint: ¿the customer states: metal shavings on the needle.No patient involved.Additional information from the customer states that the metal shavings were in the wrapping and on the needle.¿ a review of the device history record (dhr) for lot no.813829 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Inspectors routinely examine a statistical sample both physically and visually.Dhrs were also reviewed for the units assembled for this lot.Physical samples inspected from the shop orders for all involved lots identified no issues or ncrs issued against the shop orders.In addition, review for nonconformance found no ncrs issued in production of this product.A review of the entire dhr found no manufacturing or inspection anomalies.Additionally, a review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition.Process monitoring data was reviewed and there were no issues found.A review of the machine setup was conducted and revealed no issues.The exact root cause of the molding flash could not be determined based on available information.The 6m root cause analysis evaluated several contributing factors and found no issues with the manufacture of this product.There¿s insufficient information to determine a most probable root cause.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.The lot met the acceptance criteria and was released.The information reviewed showed no signs of a systemic issue with the product or process.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be utilized for tracking and 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: 7868453
• MDR Text Key: 119952654
• Report Number: 1017768-2018-00060
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: 10884521000568
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 813829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1