MAUDE Adverse Event Report: MITG - KENMEX SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number 8888266148

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2017-08-02.

Event Description

According to the reporter, on (b)(6) 2017, the device is radiopaque but was not able to be visualized via x-ray.

Manufacturer Narrative

There were no samples submitted with this complaint.The complaint shall be reopened if a sample is received.A review of the device history record could not be conducted because a lot number was not provided.The reported condition could not be confirmed.No corrective actions are deemed necessary at this time.We will keep monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer (Section G): MITG - KENMEX; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6760958
• MDR Text Key: 81624122
• Report Number: 9612030-2017-05133
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266148
• Device Catalogue Number: 8888266148
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1