MAUDE Adverse Event Report: CARDINAL HEALTH ENFIT SALEM SUMP PVC TUBE 12FR 48IN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8888264929E
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that after several attempts to place a nasogastric salem sump without success, it was noticed that the tube was not patent and in fact had no holes in the end of it.Per additional information received on 01jun2022, the device was replaced.There was no medical intervention given.
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 october 28, 2021.One sample with lot number 2129900664 was received for the investigation.A visual inspection was performed, and missing eyes (holes) were observed.The current process and controls were reviewed and found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Based on the investigation performed, a possible root cause was detected, it is possible that missing eyes could occur if brackets from the pouching machine are worn.In addition, an improvement opportunity was detected in the standard work instructions.To address the reported condition, maintenance was created for the brackets of the pouching machine and the work instructions were modified to include a 100% visual inspection by personnel production to verify that catheter has poached eyes.This complaint will be used for tracking and trending purposes.

• Brand Name: ENFIT SALEM SUMP PVC TUBE 12FR 48IN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 14642653
• Report Number: 9612030-2022-03272
• Device Sequence Number: 5574498
• Product Code: PIF
• UDI-Device Identifier: 10884521779426
• UDI-Public: 10884521779426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 07/29/2022

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: 8888264929E
• Device Catalogue Number: 8888264929E
• Device Lot Number: 2129900664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown