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

Model Number 11811022

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports: blunt fill needle had a white glue substance on the needle when taken out of package.

Manufacturer Narrative

Submission date: 01/16/2019 an investigation was performed for the reported customer complaint: the customer reports: blunt fill needle had a white glue substance on the needle when taken out of package.A review of the device history record (dhr) for lot no.15121101 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.One (1 unit ) sample was returned for evaluation.Upon visual inspection, a white glue substance was observed on the needle.There is insufficient information available to determine a probable cause.The investigation did not identify a systemic issue with the product or process.The reported customer complaint is confirmed.A root cause could not be determined.This complaint will be used 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; 15 hampshire st.; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7647806
• MDR Text Key: 112848435
• Report Number: 2183870-2018-00366
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10884521544826
• UDI-Public: 10884521544826
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 11811022
• Device Catalogue Number: 11811022
• Device Lot Number: 15121101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• 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