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	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported the flush bag spike sets are leaking continuously with several having totally exploded.

• 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: 9265968
• Report Number: 1282497-2019-08745
• Device Sequence Number: 2132324
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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
• Operator of Device: No Information
• Device Model Number: 765559
• Device Catalogue Number: 765559
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1