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

Model Number	765559
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Retention (2119)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10612620
• Report Number: 1282497-2020-09506
• Device Sequence Number: 18941892
• Product Code: LZH
• UDI-Device Identifier: 10884521155824
• UDI-Public: 10884521155824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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
• Operator of Device: No Information
• Device Model Number: 765559
• Device Catalogue Number: 765559
• Device Lot Number: 2002794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/01/2020
• Patient Sequence Number: 1