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

Model Number	11811022
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reports: blunt fill needle had a white glue substance on the needle when taken out of package.
Additional 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
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 7647806
• Report Number: 2183870-2018-00366
• Device Sequence Number: 13840469
• Product Code: GEA
• UDI-Device Identifier: 10884521544826
• UDI-Public: 10884521544826
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1