MAUDE Adverse Event Report: COVIDIEN MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881892910
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2020
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 states there is a dot of glue on the needles prior to use.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were not received for the investigation however two photos were provided.One of the photos is of the packaging, from the picture is it unclear if the package is from the lot number reported but the item code can be confirmed as 8881892910.The second photo shows the cannula, safety mechanism, and barrel of the syringe.On the cannula, it looks as though there is a foreign material approximately halfway down from the bevel end, but it is unclear if the material is clear or a white substance as would be from the lubricant or adhesive used during the manufacturing of the product.Based on a visual analysis of both photos, the reported condition could not be confirmed without a physical sample to evaluate.As a result, a definitive root cause could not be determined at this time.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.The assembly machine that this product is manufactured on is equipped with an adhesive detection station that verifies the presence of the adhesive on the needle, it contains a detect station that will reject product with bent or missing needles, and it also checks the height of the needle.Inspectors routinely examine product to ensure it meets acceptable quality limits, and a lot or shop order cannot be released unless it passes visual and physical testing requirements.During manufacturing, associates test product for needle penetration to verify that the needle is not dull or damaged.The product is tested to assure that the needle contains sufficient lubrication for ease of needle insertion during use.Associates physically test product for needle pull strength to verify that the adhesive is cured, and needles are secured per specification limits.As part of the inspection process, we perform a leak test of the syringe, which requires the associates to verify that the needle is affixed to the syringe.If problems were detected during manufacturing and testing, the non-conforming product would be rejected.During production, the processing equipment is checked regularly to verify that the detection systems are functioning properly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN INSULIN 1ML 29GX1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10544248
• Report Number: 1915484-2020-01194
• Device Sequence Number: 16925002
• Product Code: FMI
• UDI-Device Identifier: 10884521005938
• UDI-Public: 10884521005938
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 8881892910
• Device Catalogue Number: 8881892910
• Device Lot Number: 935733X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1