MAUDE Adverse Event Report: COVIDIEN 924 SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number	775759
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Samples were received in its original package.Samples were visual and functional inspected.During the functional inspection a leak was detected between the connection of the tubing line and the cross-spike connector.The reported condition will be confirmed as related to a manufacturing / production process.The root cause and corrective / preventative action (capa) plan will be documented through a formal investigation and documented within the capa.
Event or Problem Description
The customer reports the feeding tubes are leaking at spike connection, occurring with multiple sets.The leak is at the spike proximal to bag.

• Brand Name: 924 SAFETY SCREW SPIKE SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9111464
• Report Number: 1282497-2019-08665
• Device Sequence Number: 11258678
• Product Code: LZH
• UDI-Device Identifier: 20884521155739
• UDI-Public: 20884521155739
• 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): 09/24/2019

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: 775759
• Device Catalogue Number: 775759
• Device Lot Number: 183130071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1