MAUDE Adverse Event Report: COVIDIEN NEEDLE SAFETY HYPODERMIC MAGELLAN STERIL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850510

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/26/2018.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

Customer reports: a needle the nurse was about to use was found to have a long filament or lint type material on the needle shaft.

Manufacturer Narrative

Submit date: 1-feb-2019.Corrected from product #8881850515 to product #8881850510 based off follow up information.The device history record (dhr) for lot 822713 indicates no defects were found in the visual samples and no defects were found in the physical samples inspected from the lot.There were no ncrs issued against the lot.A review of the nonconformance database found no ncrs issued against the molded components or cannula used in production of this product.A review of the entire dhr found 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 in the 12 months prior to the production date.Process monitoring data is not collected for the molding machine.A review of the machine setup was conducted and revealed no issues.There was 1 sample (opened) returned with this complaint.The needle was visually examined and had a very thin piece of string flash wrapping around the cannula.The string flash originated from the gate of the safety shield, so it¿s not foreign contamination of the device.The reported condition is confirmed.The exact root cause of the molding flash could not be determined based on available information.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 foreign matter and molding flash.The lot met the acceptance criteria and was released.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: NEEDLE SAFETY HYPODERMIC MAGELLAN STERIL
• 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: 8101609
• MDR Text Key: 128271110
• Report Number: 1017768-2018-00521
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 822713
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1