MAUDE Adverse Event Report: COVIDIEN 924 SAFETY SCREW SPIKE SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	775759
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the nurse heard a dripping sound and found that the tube had fallen out of the bag.
Event or Problem Description
The customer reported that the nurse heard a dripping sound and found that the tube had fallen out of the bag.Additional information received from the initial reporter stated that the feeding set tube became disconnected from the adapter that attaches to the bag.
Additional Manufacturer Narrative
Evaluation summary: the device history record review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Samples were received in the original package.Samples were visually and functionally inspected and leaking was detected between the connection of the tubing line and the cross spike connector.The reported failure mode will be treated as confirmed and as related to the manufacturing/production process.The root cause and action plan will be documented through a formal corrective and preventative action.This complaint will be used for tracking and trending purposes.

• Brand Name: 924 SAFETY SCREW SPIKE SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9196856
• Report Number: 1282497-2019-08715
• Device Sequence Number: 16255380
• Product Code: KNT
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 05/07/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1