MAUDE Adverse Event Report: COVIDIEN 1180264531 16CH PUR SALEM W/CAP SYSTX25; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 1180264531

Device Problem Decrease in Suction (1146)

Patient Problems Adult Respiratory Distress Syndrome (1696); Death (1802); No Code Available (3191)

Event Date 05/08/2019

Event Type  Death  

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.(b)(4).

Event Description

The customer reports that the patient had a massive inhalation.Aspiration was started with a salem sump suction probe 16fr polyurethane.The maximum flow of the salem sump probe was insufficient compared with the previous pvc to manage the inhalation.Due to the insufficient flow, it was necessary to suction in the mouth with a bronchial probe in order to be able to incubate the patient.Note a total of three liters were recovered in 10-15 minutes.The patient died as a result of inhalation (acute respiratory distress syndrome and a pneumopathy of inhalation in a cancer patient).The hypothesis of insufficient flow is that the flexible light (salem sump probe) has become stuck by the pressure differential or a non-optimal positioning by excessive flexibility.Additional information provided by the initial reporter on 12-jun-2019 stated that it is not known whether the eyelets were punched out or not.Nor is it known if there was a kink in the catheter.The salem sump was being used on the stomach.It is not known if the salem sump was already in place when aspiration started.It is not known how long the tube was in place.Emergency implantation of the probe by the physician the right way.It is not known if there was output from the salem sump recorded on previous days or previous shifts.The patient did not have an ileus or bowel obstruction.

• Brand Name: 1180264531 16CH PUR SALEM W/CAP SYSTX25
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8700866
• MDR Text Key: 148056316
• Report Number: 9611018-2019-00313
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180264531
• Device Catalogue Number: 1180264531
• Device Lot Number: 19C150FHX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR