MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the luer tip where the needle and syringe connect is damaged.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.There were no samples received for evaluation however, a photograph was sent by the customer for analysis.The barrel luer tip looked to be fractured on one side.The reported condition is confirmed based on the customer provided image.A specific root cause could not be determined without an actual sample to examine and there were no related issues found in a review of the manufacturing records.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9738796
• Report Number: 1017768-2020-00798
• Device Sequence Number: 16594861
• Product Code: FMI
• UDI-Device Identifier: 10884521005846
• UDI-Public: 10884521005846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/15/2020

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: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 907744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1