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

Model Number 8881850815

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/3/2018.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

Customer states: the sterile product has a green partical inside the packaging, on the needle.

Manufacturer Narrative

Submission date: 08/23/2018.An investigation was performed for the reported customer complaint: ¿the sterile product has a green particle inside the packaging, on the needle.¿ a review of the device history record (dhr) for the reported lot number 804657 indicates product and specification requirements were met.A lot cannot be released unless it passes all quality and conformance requirements.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.During the manufacturing of the syringe assemblies, every precaution is taken to prevent contamination by foreign materials.Syringes are assembled using automated equipment, with a minimal amount of handling during processing.Inspectors routinely examine statistical samples both physically and visually.Specifically, samples are inspected for contamination and foreign matter.No physical samples were presented for evaluation.However, one (1) photo was provided.The image depicted an 18g magellan safety needle sealed in the primary package.A small green particle could be identified through the plastic film of the packaging.It could not be determined if the particle was on the needle, on the sheath, or embedded in the sheath.A 6m root cause analysis was conducted for this investigation.Without additional information or a sample, a probable root cause could not be determined.The reported condition is confirmed based on the photographic evidence.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: 7484750
• MDR Text Key: 107323538
• Report Number: 1017768-2018-00041
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521000605
• UDI-Public: 10884521000605
• 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: 08/23/2018

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: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 8881850815
• Device Catalogue Number: 8881850815
• Device Lot Number: 804657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 08/23/2018
• Date Device Manufactured: 02/19/2018
• 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