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

Model Number	7777850215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 09/27/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that the hub is broken.
Additional Manufacturer Narrative
Cardinal health has received over 46 complaints from a single customer for the same complaint of: hub split / broke.Those complaints span 2 different item numbers and multiple lot numbers.An example of the complaint is demonstrated in a submitted photo.This sample is a representative of example of all complaint samples received from this customer for hub split / broke.The hub of the safety needle was cracked completely through the luer and there was evidence of damage on the exterior of the luer from what appeared to be forcible attachment of the device.Exhaustive reviews have been conducted in the manufacturing site for the materials and the manufacturing process (previous investigation, fishbone, maps, etc.) and root cause could not be determined.Complaint investigations were completed at the date of this memo and have not identified a systemic issue with the product or processes used to manufacture the devices.Multiple tests were conducted using the affected product with both our company syringe and the syringe used by the customer.Through this testing, it was discovered that the syringe used by the customer was made of a different material other than the syringe manufactured in our site.Additionally, through multiple conversations with the vendor, the vendor acknowledged extreme tightening of the needle assembly.Therefore, the most probable root cause has been attributed to over-torquing of the polypropylene needle to a coc syringe (not manufactured by our site).This issue has been escalated to the corporate corrective and preventive action (capa) review board team for review and further decision.Due diligence has been exercised by the manufacturing facility and it has been concluded that the product continues to meet all documented design requirements.Therefore, no further actions will be taken for this specific issue 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: 6899487
• Report Number: 1017768-2017-05145
• Device Sequence Number: 16267413
• Product Code: FMI
• UDI-Device Identifier: 20884521155524
• UDI-Public: 20884521155524
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/16/2018

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: Other
• Device Expiration Date: 04/28/2021
• Device Model Number: 7777850215
• Device Catalogue Number: 7777850215
• Device Lot Number: 436464X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 02/16/2018
• Patient Sequence Number: 1