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

Model Number 1186000777

Device Problems Physical Resistance/Sticking (4012); Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing site did not receive any samples with this customer report.Without a sample, an investigation cannot be performed and the defect cannot be confirmed.Without a known lot number, the device history record cannot be reviewed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.If a sample or additional information is received at a later date this investigation will be reopened and updated as needed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer reported that the plungers are sticking and print on the syringe was missing.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9501129
• MDR Text Key: 173088995
• Report Number: 1915484-2019-01115
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

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: No Information
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1