MAUDE Adverse Event Report: COVIDIEN 777401 EPUMP ENPLUS SPIKE SET X30; JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Model Number 777401

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that during use, there was a leak noticed around the enfit connector.There is no known consequence to the patient involved.

• Brand Name: 777401 EPUMP ENPLUS SPIKE SET X30
• Type of Device: JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9505861
• MDR Text Key: 177561521
• Report Number: 9611018-2019-00378
• Device Sequence Number: 1
• Product Code: FHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

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: 777401
• Device Catalogue Number: 777401
• Device Lot Number: 18J241FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1