MAUDE Adverse Event Report: CARDINAL HEALTH, INC. SALEM SUMP; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771410E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on july 03, 2023.A physical sample was not received for investigation.However, a photo was provided.The photo showed the tip of the catheter broken (detached).The reported condition was confirmed through the photo.A corrective and preventative action has been opened to address the reported condition.All information received will be used for further tracking and trending purposes.
Event or Problem Description
The customer reported that the tip of the covidien salem sump popped right off.Additional information received on 14sep2023 stated that the incident occurred prior to patient insertion.The doctor noticed the tip was bent and it snapped off when straightening the tip.The tip did not enter the patient.

• Brand Name: SALEM SUMP
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20397257
• Report Number: 1423537-2024-00199
• Device Sequence Number: 6517523
• Product Code: PIF
• UDI-Device Identifier: 10884521582729
• UDI-Public: (01)10884521582729(17)280331(10)2317800564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Model Number: 7771410E
• Device Catalogue Number: 7771410E
• Device Lot Number: 2317800564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown