MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 775100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2018

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 stated that 1 epump screw spike set presented a leak during set up.The product was being used in hospital (b)(6).The reporter has informed that sample will not be returned for evaluation.There are no companion samples to be returned.There are no other deficient products used during the event.The patient was not involved, therefore no patient injury, medical intervention, or adverse reaction is associated with this event.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8223779
• MDR Text Key: 132348823
• Report Number: 1282497-2019-08222
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 173280093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1