MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	05/15/2024
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 when they removed the tube after the parent reported a blockage, it was noted that the entire weighted area of the nasogastric tube was missing.The tube had been in situ for 3 weeks.The 2.5 years old patient required admission and multiple x-rays to try to find missing component.There was a high degree of anxiety for the parents and child.Per additional information received, the weighted tip was not located in the patient's body.It is believed to have been passed by the infant but was not noticed by the parents.As previously reported, scans were performed to locate the missing weighted tip but produced a negative result.
Additional Manufacturer Narrative
The following sections were corrected or completed: brand name: kangaroo.Manufacturer name: cardinal health 200, inc.Unique identifier (udi) #:(b)(4).Pma/510(k)number: k833621 labeled for single use: yes.Investigation summary: decontaminated samples were received at the plant for the investigation.The device history record for the possible lots were reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the reported issue was confirmed; a ruptured tube was found in 1 of the samples.A root cause analysis indicated that this occurred during our manufacturing process.
Additional Manufacturer Narrative
Investigation summary: decontaminated samples were received at the plant for the investigation.The device history record for the possible lots were reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the reported issue was confirmed; a ruptured tube was found in 1 of the samples.A root cause was unable to be determined at this time.Corrected investigation summary.From: decontaminated samples were received at the plant for the investigation.The device history record for the possible lots were reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the reported issue was confirmed; a ruptured tube was found in 1 of the samples.A root cause analysis indicated that this occurred during our manufacturing process.To: decontaminated samples were received at the plant for the investigation.The device history record for the possible lots were reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the samples, the reported issue was confirmed; a ruptured tube was found in 1 of the samples.A root cause was unable to be determined at this time.Corrected h6 evaluation codes: from: 125, to: 180.From: 25, to: 4315.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19519550
• Report Number: 9612030-2024-00085
• Device Sequence Number: 6080936
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: (01)10884521582972
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 8884720858E
• Device Catalogue Number: 8884720858E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/26/2024; 08/28/2024
• 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