MAUDE Adverse Event Report: COVIDIEN 1000ML LRG BORE GRAVITY SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	702505
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
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
Customer reports: gravity bags are leaking.
Additional Manufacturer Narrative
A device history record review could be performed since the reported lot number was unknown.Samples were received at the manufacturing site for evaluation.A visual and functional inspection was conducted, and the results were that a detached connector from the line was observed.The reported issue was confirmed.The most likely root cause could be related to a manufacturing/production process issue due to inadequate cyclohexanone dispensing.Corrective action has been taken by increasing maintenance of the equipment so that it operates correctly, dispensing the adequate amount of cyclohexanone.A quality alert will be issued to personnel to notify them of the reported condition and the changes to be implemented and verification that the new process is working correctly.

• Brand Name: 1000ML LRG BORE GRAVITY SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11745518
• Report Number: 1282497-2021-10132
• Device Sequence Number: 16949741
• Product Code: KNT
• UDI-Device Identifier: 10884521002197
• UDI-Public: 10884521002197
• 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): 10/01/2021

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: 702505
• Device Catalogue Number: 702505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1