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

Model Number 775759

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

Event Type  malfunction  

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 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
• 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: 9111464
• MDR Text Key: 159935979
• Report Number: 1282497-2019-08665
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 20884521155739
• UDI-Public: 20884521155739
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1