MAUDE Adverse Event Report: COVIDIEN MAGELLAN; SYRINGE, PISTON

Model Number	8881892950
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: (b)(6) 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 or Problem Description
The customer reports: when using (opening the cap) it was noticed, that a piece of plastic was sticking at the needle (color similar to the color of the cap).
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reports: when using (opening the cap) it was noticed, that a piece of plastic was sticking at the needle (color similar to the color of the cap).¿ a review of the device history record (dhr) for lot no.815113x 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.Potential issues that are inspected for include, but are not limited to, damaged product or components, flash, incomplete or incorrect assembly of product, clogged or partially occluded needle or cannula, leak testing, and syringe silicone amount testing.Leak testing is conducted to ensure the syringe draws, holds and expels fluid properly.Periodic audits are conducted to ensure the quantity of barrel inner dimension silicone lubricant is within specification limits.Procedures and standard work instructions exist for the setup, operation, and maintenance of the molding machines, printers, and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.During the manufacturing of this lot, syringes were visually inspected and physically tested with no issues recorded relating to this customer report.Specifically, throughout the manufacture of this product, a minimum of one index (sample set) is collected and visually inspected at least once every 30 minutes to one (1) hour, depending on current sampling plan, to inspect for visual abnormalities including but not limited to damaged product or components, flash, and incomplete or incorrect assembly of product.Throughout the length of each production run, depending upon the current sampling plan, one complete index (sample set) is collected at least every 3-12 hours to perform physical testing.It is important to note, all raw materials purchased and used in the manufacture of products are from approved suppliers only.This syringe is intended to be a single use syringe and not qualified as a prefill syringe.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 information reviewed showed no signs of a systemic issue with the product or process.Therefore, no corrective actions will be taken at this time.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• MDR Report Key: 8025256
• Report Number: 1915484-2018-00048
• Device Sequence Number: 1194917
• Product Code: FMF
• UDI-Device Identifier: 10884521005945
• UDI-Public: 10884521005945
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 8881892950
• Device Catalogue Number: 8881892950
• Device Lot Number: 815113X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1