MAUDE Adverse Event Report: COVIDIEN 6ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number 8881516200

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

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.

Event Description

The customer reports that a syringe was found with a cardboard like particulate inside the barrel.

Manufacturer Narrative

The lot number identified was invalid.A review of the device history record (dhr) was unable to be performed.However, 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 photograph was provided for evaluation.According to the image, the issue was observed as cardboard contamination in the syringe.The 60ml syringe, luer lock tip, is manufactured by an external supplier.The processing site operations consist only of the assembly (pick and place) into the operation tray.The syringes undergo a subsequent process after they leave this facility.The condition reported did not occur during the assembly manufacturing process.The reported customer complaint is confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 6ML LUER LOCK PHARMACY TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8199621
• MDR Text Key: 131507013
• Report Number: 9612030-2018-02068
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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
• Device Operator: Other
• Device Model Number: 8881516200
• Device Catalogue Number: 8881516200
• Device Lot Number: 1820408654
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 02/13/2019
• Patient Sequence Number: 1