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

Model Number 8881850510

Device Problems Leak/Splash (1354); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

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 states the item has fiber contamination and leaking hubs.

Manufacturer Narrative

A review of the device history report (dhr) for lot no.820101 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.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.The dhrs for shop order production of the safety needles identified no issues.There were no ncrs issued against the shop orders.A review of the entire dhr identified 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 no process or material changes related to the reported condition for this product.Additionally, a review of the machine setup was conducted and revealed no issues.A review of the manufacturing equipment was performed as part of this investigation.The review found no issues with the equipment or process related to the reported condition.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 6m root cause analysis for the reported issue of contamination did not identify any issues with the manufacturing process for the needles that would have caused this issue.The complaint file contains insufficient information to determine a most probable root cause.The 6m root cause analysis for the reported condition of leaking 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 customer out of specification), but there¿s insufficient information to determine whether those factors were the true root cause.The reported customer complaint(s) could not be confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.This complaint will be utilized for tracking and trending purposes.

• Brand Name: SAFETY NEEDLE 25 X 1
• 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: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8152416
• MDR Text Key: 130050790
• Report Number: 1017768-2018-00536
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 820101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1