MAUDE Adverse Event Report: COVIDIEN PREVENT NEEDLE ONLY 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	26559
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2020
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: upon opening the product, contamination was observed on the needle.
Additional Manufacturer Narrative
H 3 evaluation summary the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected from the lot.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 for fluid path and needle contamination.There was 1 sample and 3 photos returned with this complaint.The reported condition was confirmed.The exact root cause could not be determined based on available information.The shop orders used for this lot met all defined acceptance requirements and were released.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a corrective and preventative action (capa) is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT NEEDLE ONLY 25 X 1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9581830
• Report Number: 1017768-2020-00774
• Device Sequence Number: 13586987
• Product Code: FMI
• UDI-Device Identifier: 10612479201382
• UDI-Public: 10612479201382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 26559
• Device Catalogue Number: 26559
• Device Lot Number: 927003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1