MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR FEED TUBE 5 FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461503
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the tube was going to be replaced with lot #2231310564 but the replacement tube was split in two and not used.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot was reviewed and showed that manufacturing and product inspection was performed as per applicable procedures and validated process.One used decontaminated sample outside of its original packaging was received for evaluation.The sample was visually inspected; the catheter showed signs of use such as residues of a yellow substance and the tube was broken, the stabilizer butterfly is detached and there is also adhesive residue on the tube.Therefore, the condition reported by the customer was confirmed.The root cause could be associated to an omission gap error by personnel due to attention management by the operator during the solvent application process.A quality alert was issued to the focus factory personnel, summarizing the reported event to heighten awareness and prevent the recurrence of the reported issue during the manufacturing process.

• Brand Name: POLYUR FEED TUBE 5 FR X 36
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 17283437
• Report Number: 9612030-2023-03755
• Device Sequence Number: 6176855
• Product Code: KNT
• UDI-Device Identifier: 20884521067971
• UDI-Public: 20884521067971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 461503
• Device Catalogue Number: 461503
• Device Lot Number: 2231310564
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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