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

Model Number	7771610E
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 may 08, 2023.There were no physical samples or photos received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.However, a corrective and preventative action has been opened to address the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.All information received will be used for further tracking and trending purposes.
Event or Problem Description
The customer reported that he tested the device by hand to see how easily the tip can come off and it came off but not as easily.There was no patient involvement.

• 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: 20397268
• Report Number: 1423537-2024-00200
• Device Sequence Number: 6517528
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: (01)10884521582736(17)280229(10)2311800364
• 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
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Device Lot Number: 2311800364
• 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: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown