MAUDE Adverse Event Report: COVIDIEN JOEY SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number 765559

Device Problem Fluid/Blood Leak (1250)

Patient Problem Urinary Retention (2119)

Event Type  malfunction  

Event Description

The customer reported out of the case, the client has had 15 sets that were leaking at the connector where the tube connects to the pump.There was no patient harm.

• Brand Name: JOEY SAFETY SCREW SPIKE SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10612620
• MDR Text Key: 209354918
• Report Number: 1282497-2020-09506
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155824
• UDI-Public: 10884521155824
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 765559
• Device Catalogue Number: 765559
• Device Lot Number: 2002794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1