MAUDE Adverse Event Report: COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON

Model Number 8881512258

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

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 reported there was an insect in the syringe barrel.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One digital image was provided and one syringe outside of the original package was received for evaluation.A visual inspection of the sample confirmed the reported issue; the syringe was contaminated.The manufacturing process was reviewed by a multifunctional team and determined that the process is running according to product specifications, meeting quality acceptance criteria.The equipment used for the catheter-adapter assembly was verified and found to be up to date for all corrective and preventive maintenance as scheduled.

Manufacturer Narrative

The supplier provided the following information after investigating the reported issue: the supplier confirmed that a contaminate was embedded in the rubber tip and the insect has the complete shape of the part.The parts were produced in (b)(6) 2019.The supplier stated that the insect contamination happened after their calendaring process, and their calendaring and molding workshop are a normal environment, not a clean room.After brainstorming, the supplier determined that the current pest control actions may not be strong enough during the mosquito season, which caused the insect to have the possibility to contaminate the preform film and be molded in the part.The supplier reviewed their current pest controls and the following fixes were completed: 1) added additional mosquito killer lamps at the compounding workshop and molding workshop.2) updated the pest control procedure to define the frequency of cleaning the mosquito killer lamps and the frequency of lamp replacement.Furthermore, the supplier alerted the relative operators and inspectors of the reported issue.The in-house stock was double checked.Resampling inspection of 29 lots found no defects.The supplier strengthened their sampling inspection.These actions were designed to prevent the reoccurrence of the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10673852
• MDR Text Key: 211495493
• Report Number: 9612030-2020-02657
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 2014008664
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2020
• Patient Sequence Number: 1