MAUDE Adverse Event Report: COVIDIEN MONOJECT; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 8881540133

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 6/22/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports: nurse manager opened packaging to see a black substance the cannula.

Manufacturer Narrative

Submission date: 08/27/2018.Section d: lot no: s14365.An investigation was performed for the reported customer complaint: ¿the customer reports: nurse manager opened packaging to see a black substance the cannula.¿ a review of the device history record (dhr) for lot number s14365 indicates product and specification requirements were met.A lot cannot be released unless it passes all quality and conformance requirements.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.During the manufacturing of the syringe assemblies, every precaution is taken to prevent contamination by foreign materials.Syringes are assembled using automated equipment, with a minimal amount of handling during processing.Inspectors routinely examine statistical samples both physically and visually.Specifically, samples are inspected for contamination and foreign matter.No nonconforming issues were identified for the molded smartip components used in the production of the lot.Maintenance records (corrective and preventive), machine set-up, calibration records, process monitoring data and machine set up were all reviewed with no issues noted.There were no changes to the process or materials related to the reported event for this product.One (1) opened and unused sample was received for evaluation.A visual inspection of the sample confirmed the presence of a black substance.The substance could not be removed by physical (wiping) or chemical (isopropyl alcohol) means.Based on the results of testing, the substance was most likely embedded in the material.A 6m root cause analysis was performed.The most probable root cause was identified as burnt resin broke loose from the inside of the barrel of the injection molding machine and became embedded in the plastic.This condition was most likely created during a random event during the molding process.The issue presents a negligible risk to the patient, because the specks were embedded in the plastic and would not come in contact with the patient.There¿s no indication of a systemic issue with the process or product.The reported customer complaint is confirmed.A most probable root cause was identified as burnt resin broke loose from the inside of the barrel of the injection molding machine and became embedded in the plastic.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• Manufacturer (Section G): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7630593
• MDR Text Key: 112158712
• Report Number: 1017768-2018-00048
• Device Sequence Number: 1
• Product Code: GEA
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: S14365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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