MAUDE Adverse Event Report: COVIDIEN LP/LLC, DELAND MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850558

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

There were two unopened samples submitted with this complaint.A visual inspection of the hub for damage was performed.The luer taper of the needle hub was measured and a leakage test was performed.The samples met specification of all the testing performed.The reported condition could not be confirmed.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 Description

The customer reported in the administration of the vaccines of the children's examinations, during the process of injection of one of the vaccines with safety needle there is loss of a part of the vaccine liquid.

Manufacturer Narrative

An investigation of the reported condition was performed.The samples were received, and the investigation was updated.The device history record (dhr) for lot indicates zero issues were found in both visual and physical samples inspected from the lot.There were no non-conformance reports (ncr) issued against this lot.A review of maintenance records (both corrective and preventive) and calibration records were reviewed, and no issues related to the reported condition were identified.All scheduled maintenance and calibration activities were completed.A review of the process monitoring data was conducted and did not reveal any issues related to the reported condition.A review of the machine setup was conducted, and no issues related to the reported condition were identified.There were two unopened samples submitted with this complaint.A visual inspection of the hub for damage was performed.The luer taper of the needle hub was measured and a leakage test was performed.The samples met specification of all the testing performed.The reported condition could not be confirmed.The exact root cause of the reported condition could not be determined based on the available information.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 luer taper, hub leaks, and damage.The lot met all defined acceptance requirements and was released.Based on the investigation findings and the information available, a corrective and preventive action is not deemed necessary at this time, as there was no indication of a systemic issue with the process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN LP/LLC, DELAND; 2010 e international speedway; deland FL 32724 8707
• Manufacturer (Section G): COVIDIEN LP/LLC, DELAND; 2010 e international speedway; deland FL 32724 8707
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6859590
• MDR Text Key: 85958874
• Report Number: 1017768-2017-05125
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: 10884521000575
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 503355X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 05/11/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1