MAUDE Adverse Event Report: COVIDIEN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 7070005

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 6/18/2018.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.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: during the filling process, a blue foreign substance was observed surrounding the needle portion of the needle assembly.

Manufacturer Narrative

Submission date: 08/24/2018.An investigation was performed for the reported customer complaint: ¿the customer reports: during the filling process, a blue foreign substance was observed surrounding the needle portion of the needle assembly.¿ a review of the device history record (dhr) for the reported lot number 728917 indicates product and specification requirements were met.A lot cannot be released unless it passes all quality and conformance requirements.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.Control mechanisms are in place to maintain product quality.These include, but are not limited to: material verification/certification processes, dimensional specifications, machine maintenance requirements, particulates and extraneous matter and embedded particulates and extraneous matter, or inclusions in molded parts, and personnel training/certification.A review of changes to product and process has been conducted identifying no affecting changes related to this reported event.A review of maintenance records (both corrective and preventive), including calibration records, contained no issues.All scheduled maintenance and calibration activities were completed.Process monitoring data for the lot was reviewed and there were no issues.Machine setup was evaluated with no issues.The assembly machine and the final product screening table did not show any contamination.There was one (1) used sample returned for evaluation.The sample was examined using 30x magnification and a blue fiber-like material could be seen wrapped around the cannula near the ferrule.Meridian confirmed the foreign material was polyester (pet) and confirmed the material matched the blue lint free cloth utilized in cleaning the screening table.The most likely root cause is that the blue cloth caught on something on the final product screening table and it subsequently attached to the needle.If the contamination had been from the assembly machine during the passivation process the nitric acid would have removed the color from the fiber.It is important to note that polyester (pet) is not used in the manufacturing of the product.The following items were reviewed and do not contain polyester (pet): brushes on machine, inspection brush, finished goods container and lid, resin used at the plant, tape, bubble wrap, bags.A work order has been opened to review and remove any sharp edges on the final product screening table.It has been documented that the blue lint free cloth will no longer be used to clean the final product screening table.Procedure will be updated indicating kimwipes and a vacuum will be used for cleaning the screening table.The reported customer complaint is confirmed.The probable root cause was determined to be a blue lint free cloth utilized at the product screening table.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: NA
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 7609782
• MDR Text Key: 111339234
• Report Number: 1017768-2018-00046
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 7070005
• Device Catalogue Number: 7070005
• Device Lot Number: 728917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2018
• 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