MAUDE Adverse Event Report: COVIDIEN MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850015
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 8/22/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer states something like hair or plastic is in the needle while doing process for medication.A patient was involved but was not injured and did not require medical intervention.
Additional Manufacturer Narrative
The device history record (dhr) for lot s14216 indicates that there were no defects found in (b)(4) visual samples and (b)(4) physical samples inspected from the lot.There were no samples returned for evaluation therefore the exact root cause could not be determined based on available information.A 6m root cause analysis was performed and analyzed several potential contributing factors.The analysis found no evidence of issues that would have cause the reported condition.Based on the available information there¿s insufficient evidence available to determine a most probable root cause for this investigation.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 contamination and foreign matter.The lot met all defined acceptance criteria and was released.A specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the process or product, so a capa is not necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 6811825
• Report Number: 1017768-2017-05119
• Device Sequence Number: 19349473
• Product Code: FMI
• UDI-Device Identifier: 20884521000497
• UDI-Public: 20884521000497
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 01/31/2022
• Device Model Number: 8881850015
• Device Catalogue Number: 8881850015
• Device Lot Number: S14216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1