MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP W/ARV 18 FR CE/INTL; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	266148
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the probe bent in the esophagus.The probe was repositioned and remained in the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.Sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Because no photo or sample was available for evaluation, a possible root cause could not be determined.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.A risk assessment was carried out to determine the observed occurrence for reported failure mode.Based on the investigation, no further actions are being pursued.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Type of investigation was corrected to 4114 device not returned.

• Brand Name: SALEM SUMP W/ARV 18 FR CE/INTL
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15121562
• Report Number: 9612030-2022-03339
• Device Sequence Number: 15284666
• Product Code: FEG
• UDI-Device Identifier: 10884521065055
• UDI-Public: 10884521065055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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
• Device Model Number: 266148
• Device Catalogue Number: 266148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 07/27/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/23/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown