MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE CATHETER TIP SYRINGE, PISTON

Model Number 1186000444

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that there was resistance when flushing the peg tube. The contents of the syringe escaped out at the back of the barrel after passing around the plunger tip. The customer further added that the plunger was not sealed with the barrel. There was no injury to the patient or staff.

• Brand Name: 60ML SYRINGE CATHETER 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: 9808472
• Report Number: 1915484-2020-01142
• Device Sequence Number: 1
• Product Code: FMF
• 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

• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1186000444
• Device Catalogue Number: 1186000444
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage