MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 18 X 1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850815
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that when the needle was placed on a syringe, liquid is spraying out of the pink connection piece.The customer further stated that when screwing it on to the syringe, it doesn't seat and the device will spin free.There was no patient harm reported.
Additional Manufacturer Narrative
A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.There were no samples returned with this complaint so the exact nature of the reported condition could not be determined.The 6m root cause analysis did not identify any issues with the manufacturing process for the needles that would have caused this issue.There were two potential root causes identified during the investigation pertaining to the user (attachment method) and material syringe (sourced by the customer out of specification), but there¿s insufficient information to determine whether those factors were the true root cause.Prior to a lot¿s release, the lot must be deemed acceptable; 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 leaking.The lot met the acceptance criteria and was released.As the reported condition was not confirmed and there were no related issues found in a review of manufacturing records and based on the available information, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SAFETY NEEDLE 18 X 1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10349759
• Report Number: 1017768-2020-00836
• Device Sequence Number: 16898445
• Product Code: FMI
• UDI-Device Identifier: 10884521000605
• UDI-Public: 10884521000605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 8881850815
• Device Catalogue Number: 8881850815
• Device Lot Number: 004115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/23/2020
• Patient Sequence Number: 1