MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 25 G X 1"; 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 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states: they are finding ¿fuzz¿ on the needle.

Manufacturer Narrative

The device history record (dhr) for lot 821913 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 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 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 needle assembly (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.An issue impact assessment was conducted for magellan gate strings in june of 2018.The biocompatibility testing report for the magellan safety needles (5/7/2012) revealed that the product demonstrated no evidence of cytotoxicity, the material has no evidence of potential sensitization, no evidence of hemolysis and no evidence of acute systemic toxicity.The biocompatibility testing report confirms the potential harm is low risk.The overall risk score of the defect was ¿low¿ for issue impact assessment.Based on the low risk associated with the issue, no additional corrective action will be taken at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SAFETY NEEDLE 25 G 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8199251
• MDR Text Key: 131499460
• Report Number: 1017768-2018-00542
• 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: 02/01/2019

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: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 821913
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1