MAUDE Adverse Event Report: COVIDIEN SALEM SUMP PVC TUBE 10FR 36IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888264911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the tip of the salem sump tube was found broken during daily checks of the tube.The tube is used to remove accumulation of saliva in the esophagus using a suction unit, with 40 mmhg pressure.The customer further clarified the tip they are referring to is at the end where the holes are.The breakage happened at one of the holes but is still attached to the tube.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One decontaminated sample with lot number 1914405464 was received for evaluation.In addition, a photo was provided.After performing a visual inspection the reported issue was confirmed, the tubing was observed to have a cut tip.A gemba walk was performed by the multifunctional team (engineering, quality, production), and it was determined that the most probable root cause could be that the current fixture doesn't allow the operator to have proper visibility while doing the punching.As part of continuous improvements, a quality alert will be implemented and improvements will be made to the fixture, changing the current material to a light color.The process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: SALEM SUMP PVC TUBE 10FR 36IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9290404
• Report Number: 9612030-2019-02344
• Device Sequence Number: 1864634
• Product Code: KNT
• UDI-Device Identifier: 10884521007666
• UDI-Public: 10884521007666
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/15/2020

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: 8888264911
• Device Catalogue Number: 8888264911
• Device Lot Number: 1914405464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1