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

Model Number	26559
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
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 the needle was flimsy and protruded through the plastic of the safety shield.There was no harm associated with this event.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) for the reported lot indicates no issues were found in physical and visual samples inspected from the lot.A review of the entire dhr¿s showed no manufacturing or inspection anomalies.All scheduled maintenance and calibration activities were completed.There were no samples and 2 photos returned with this complaint.The reported condition could not be confirmed with photos.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 shield stall/locking failure and hinge pull test.The shop orders used for this lot met all defined acceptance requirements and were released.The true root cause of the failure could not be determined based on available information.There were no anomalies found during a review of the dhr, maintenance records or process monitoring data.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: 10750906
• Report Number: 1017768-2020-00882
• Device Sequence Number: 19274457
• Product Code: FMI
• UDI-Device Identifier: 10612479201382
• UDI-Public: 10612479201382
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 015364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1