MAUDE Adverse Event Report: COVIDIEN 25G X 2 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881200441

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

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 Description

The customer reports: white particles were found loose on needles.

Manufacturer Narrative

The device history record (dhr) for lot number 822529 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no changes to the material related to the reported condition for this product.A review of the process monitoring data was conducted and no issues were found.A review of the machine setup was conducted and there were no issues.A review of the entire dhr review did not identify manufacturing or inspection anomalies.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The investigation analysis did not identify any issues with the manufacturing process that would have caused this issue.Based on the available information there¿s insufficient evidence to determine a most probable root cause for this investigation.The investigation did not identify a systemic issue with the product or process and a specific root cause could not be identified.Based on the information available, no corrective and preventive action will be taken at this time.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for trending purposes.

• Brand Name: 25G X 2 A (ALUM HUB) RP
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8019216
• MDR Text Key: 125626568
• Report Number: 1017768-2018-00513
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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
• Device Operator: Health Professional
• Device Model Number: 8881200441
• Device Catalogue Number: 8881200441
• Device Lot Number: 822529
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1