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

Model Number 8881850510

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2018

Event Type  malfunction  

Event Description

The customer states there are fibers on the needle inside the packages.Upon review of the photos provided, there appears to be loose fibers on the needles.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards; no non-conformances were issued against the lot or shop order and no defects were found in the visual samples and no defects were found in the physical samples inspected from the lot.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.Samples were received for evaluation and the reported condition is confirmed; samples had the presence of string flash extending from the gate of the safety shield and wrapping around the needle.The most likely root cause was due to flash, which is stringy plastic material attached at the molded part's gate (the entrance to the mold cavity) forming when melted plastic resin remains at the injection gate as the two mold halves separate.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 (b)(4) of 2018.The biocompatibility testing report for the magellan safety needles 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 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: 8137623
• MDR Text Key: 129480318
• Report Number: 1017768-2018-00532
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 820100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2018
• 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: N
• Patient Sequence Number: 1