MAUDE Adverse Event Report: COVIDIEN SALEM SUMP W/ ARV 18FR. 48IN; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266148
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2019
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 reports that the very tip of the device is almost disconnected and jagged causing pain to the patient when they pull it out.The tube was to be used for suction.Further continuous observation was done for the patient.The health care provider decided not to insert the tube.There was no injury to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards one decontaminated sample without original package or lot number was received for evaluation.After performing a visual inspection based on our procedure, tip damage was observed.A gemba walk was performed at the manufacturing area with the multifunctional team (quality, manufacturing, engineering) and no deviation from the validated process has been found.After reviewing the reported sample clear evidence of its usage can be seen, suggesting that there was handling after the manufacturing process, therefore it cannot be confirmed if the issue originated before or after the manufacturing.The manufacturing personnel involved in the process were notified about the reported condition.The issue was not confirmed to be manufacturing related; the current manufacturing process has been reviewed and currently meets all quality and manufacturing specifications.No further actions are considered necessary at this time.

• Brand Name: SALEM SUMP W/ ARV 18FR. 48IN
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8920524
• Report Number: 9612030-2019-02254
• Device Sequence Number: 11336563
• Product Code: FEG
• UDI-Device Identifier: 10884521004726
• UDI-Public: 10884521004726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 8888266148
• Device Catalogue Number: 8888266148
• Device Lot Number: 1834538964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1