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

Model Number	8881512258
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
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.
Event or Problem Description
The customer states a foreign matter was found on one syringe underneath the head and along the upper half of the plunger.
Additional Manufacturer Narrative
A sample without original package or lot number was received for evaluation.After performing an evaluation contamination was observed in the syringe.The device history record file was reviewed indicating that the product was released meeting all quality standard requirements.As part of continuous improvements, a corrective action has been opened.These actions are designed to determine the root cause and implement the appropriated corrective action(s) to prevent the reoccurrence of the reported defective condition.This complaint will be used for qa tracking and trending.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8603827
• Report Number: 9612030-2019-02172
• Device Sequence Number: 1857468
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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
• Operator of Device: No Information
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 1728580664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1