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 Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

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 reports: there is a black substance present around the hub of the needle.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.822713 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.Additionally, dhrs for the shop orders of the safety needles assembled for this lot were also reviewed.Physical samples inspected from the shop orders indicated no issues were identified.There were no ncrs (nonconformance records) issued against the shop orders.There were also no ncrs issued against the molded hubs 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.A review of the machine setup was conducted and revealed no issues.This device is manufactured in a controlled and monitored environment and goes through the following processes: injection molding, needle assembly and packaging.These processes are highly automated with limited human interaction.The equipment was reviewed for issues that could have potentially caused this issue, but not were identified.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 did not identify any issues with the manufacturing process for the needles that would have caused this issue.The information reviewed showed no signs of a systemic issue with the product or process.The complaint file contains insufficient information to determine a most probable root cause.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

One (1) sample was returned for evaluation.The sample was visually inspected and black material was seen on the hub.The issue of unidentified matter was observed.Based on the results of the sample evaluation, the most probable root cause was identified as burnt resin that broke loose from the inside of the barrel of the injection molding machine and became embedded in the plastic (inclusions).The issue presents no risk to the patient, because the inclusions are embedded particles of parental material for the device.There were no manufacturing or inspection anomalies found during the investigation.The available information indicates the issue was most likely a result of an isolated event.The reported customer complaint is confirmed.A root cause could not be determined.The most probable root cause was determined to be burnt resin that broke loose from the inside of the barrel of the injection molding machine and became embedded in the plastic.No corrective or preventive action is planned at this time.This complaint will be used 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8048274
• MDR Text Key: 126512492
• Report Number: 1017768-2018-00517
• 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,Followup
• Report Date: 02/28/2019

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: 822713
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 10/24/2018
• Supplement Dates FDA Received: 12/13/2018; 02/28/2019
• 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