MAUDE Adverse Event Report: COVIDIEN 14G X 1 1/2 IN (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
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 reports there was leakage observed between the metallic part of the needle and its support.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot number showed no manufacturing or inspection anomalies.A review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were 1,000 samples returned with this complaint record.Out of the 1,000 samples, a random number of samples were evaluated, and no leakage was noticed.Therefore, the reported condition could not be confirmed.The exact root cause could not be determined based on available information.The 6m root cause analysis did not identify any issues with the manufacturing process that would have caused this issue.There was one potential root cause identified during the investigation which pertain to be a user error.But there¿s insufficient information to determine whether those factors were the true root cause.The application of the device could not be verified from the information present in the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.The inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for leakage in the fluid pathway.The lot met all the acceptance criteria and was released.It is recommended that the user should refer to the instructions for use for more information.Since there were no findings related to the reported condition, no corrective actions are required at this time.

• Brand Name: 14G X 1 1/2 IN (ALUM HUB) RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8611473
• Report Number: 1017768-2019-00641
• Device Sequence Number: 1860036
• Product Code: FMI
• UDI-Device Identifier: 30884521007486
• UDI-Public: 30884521007486
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/08/2019

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: 8881200011
• Device Catalogue Number: 8881200011
• Device Lot Number: 904218
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1