MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1186000777
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the syringe appears to have flakes of some sort in the barrel.No patient injury was reported.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two photos were provided for the investigation.The photos were visually evaluated.In the first photo, the syringe lidding with identifying product information can be observed.In the second photo, a portion of an unpackaged syringe can be observed with what appears to be cardboard particulate within the ribs and on the face of the rubber tip within the fluid pathway.On (b)(6) 2021, one syringe was received in an unsealed package for evaluation.Visual inspection to the quality inspection standard was conducted and cardboard particulate was observed on the face and side of the rubber tip.A review of the product flow identified there to be no cardboard stored in any of the immediate production molding and assembly areas.The most probable root cause for the cardboard contamination is likely due to cardboard debris from the shipper case of the stoppers.All stoppers are received double-bagged within a shipper case.During preparation for stopper tumbling, the associate will place the shipper on a table where they will open and remove the inner bag of stoppers from the outer bag and shipper.The inner bag may become contaminated if it is received with cardboard contamination from the vendor.Another potential cause may be if the inner bag is placed on the table which may contain cardboard debris.If the bag has cardboard debris on the outside of it, when the bag is poured into the tumbler, the cardboard debris could contaminate the stoppers.When the glycerin coating is added, this could cause the cardboard debris to adhere to the stopper(s).As part of continuous improvements, a quality alert will be distributed to the necessary quality and production personnel to heighten awareness of the reported condition and recommend best practices.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11849031
• Report Number: 1915484-2021-01246
• Device Sequence Number: 17080479
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: No Information
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 030046X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/08/2021
• Patient Sequence Number: 1