MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/25/2020
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 reported that when the nurse opened the package for syringe preparation, she noted that the base of the needle was broken off inside the syringe.The issue was noticed before use.
Additional Manufacturer Narrative
A device history record showed no manufacturing or inspection anomalies.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.One sample and two representative photographs were provided for product analysis.The photograph and sample confirmed that the device did have a broken hub.A 6m root cause analysis did not identify any issues with the manufacturing process for the needles that would have caused this issue.There was one potential root cause identified during the investigation pertaining the manufacturing equipment however, there was insufficient information to determine whether this factor was the true root cause.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for hub damage.The lot met the acceptance criteria and was released.

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10338464
• Report Number: 1017768-2020-00835
• Device Sequence Number: 19577780
• Product Code: FMI
• UDI-Device Identifier: 10884521005815
• UDI-Public: 10884521005815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/13/2020

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: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 907743
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1