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

Model Number 1181200777

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

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 stated that a brown spot was found inside the syringe.No patient injury was reported.

• Brand Name: 12ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12139078
• MDR Text Key: 260600657
• Report Number: 1424643-2021-00609
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010000
• UDI-Public: 10884521010000
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 1181200777
• Device Catalogue Number: 1181200777
• Device Lot Number: 20A08563X
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1