MAUDE Adverse Event Report: COVIDIEN 1ML MAGELLAN 25 X 1 COMBO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881811510
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported before opening the package they noticed there was something on the needle.
Additional Manufacturer Narrative
A device history record review of the reported lot number, p101173x, confirmed that the product was produced accomplishing quality requirements and released according to established procedures.One packaged sample was received for evaluation.A visual inspection was conducted, and foreign matter was observed on the needle of the hooded needle assembly.The needle was looked at 7x magnification for evaluation of the foreign matter.The foreign matter appears to be orange plastic material from the hooded needle hub.From the evaluation of the returned sample, the most likely root cause for the foreign material on the needle is particulate from the needle hub became stuck to the needle during the manufacture of the hooded needle that was attached to the sample.Under 7x magnification it was noted that the foreign material had an orange appearance which was similar in nature to what the hub is made from.Every precaution is taken when manufacturing this product to prevent contamination by foreign materials.During manufacturing, syringes are assembled using automated equipment, with a minimal amount of handling during processing.The machines, molds, syntrons, hoppers and trays are wiped down regularly.Totes are lined with plastic bags to prevent contamination.A formal corrective and preventative action is not necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML MAGELLAN 25 X 1 COMBO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11605581
• Report Number: 1915484-2021-01223
• Device Sequence Number: 14357967
• Product Code: FMI
• UDI-Device Identifier: 10884521005891
• UDI-Public: 10884521005891
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: No Information
• Device Model Number: 8881811510
• Device Catalogue Number: 8881811510
• Device Lot Number: P101173X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1