MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 18 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850810

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The customer provided samples and the defect of string flash was identified and confirmed.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.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.Corrective / preventive actions: an issue impact assessment was conducted for magellan gate strings.The overall risk score of the defect was ¿low¿ for that assessment.Based on the low risk associated with the issue, no additional corrective action will be taken at this time.

Event Description

The customer states: the needles sometimes have a piece of string like plastic stuck toward the bottom of the needle.

• Brand Name: SAFETY NEEDLE 18 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: 7953410
• MDR Text Key: 123373610
• Report Number: 1017768-2018-00509
• 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
• Report Date: 10/10/2018

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: 8881850810
• Device Catalogue Number: 8881850810
• Device Lot Number: 820825
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/10/2018
• 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