MAUDE Adverse Event Report: MITG - KENMEX SALEM SUMP; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888264960
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-07-28.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the initial reporter they discovered a hole in the tube at the top of the blue vent port through the sump tube opening which caused the sump to leak at the blue vent junction.The issue was discovered after placement and during use on a patient.They're moved it and put another one in which was also leaking.They found four others from the same lot number that all appeared to have a hole on the blue valve at the junction point to the clear sump tubing.No patient injury reported.
Additional Manufacturer Narrative
The sample was not received at the manufacturing site for evaluation.The inspection was performed based on pictures that were provided.The reported condition could not be confirmed by the pictures.The device history record file was reviewed indicating that product was released meeting all quality standard requirements.A review of the current process has been executed detecting all functions working properly.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SALEM SUMP
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• MDR Report Key: 6750063
• Report Number: 9612030-2017-05128
• Device Sequence Number: 13763763
• Product Code: KNT
• UDI-Device Identifier: 20884521007724
• UDI-Public: 20884521007724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 8888264960
• Device Catalogue Number: 8888264960
• Device Lot Number: 706618864X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1