MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the 8fr ng tube tip broke off while in place.The mom noted resistance 1.5 weeks ago following administration of medication but was eventually able to flush the tube with water again.No further issues were noted by the family but upon ct scan review by radiologist on (b)(6), the tip of ng tube was seen in the small intestine.The patient has not yet passed the tip of ng tube but the remainder of the tube was removed in the clinic.Per additional information provided on 24nov2025, the ct scan was performed on (b)(6), not (b)(6) which was initially reported in error.This was a routine scan for monitoring purposes with regards to the patient's medical history.As of last thursday, the tip of the ng tube had not passed yet.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
One incomplete device was received for investigation.A portion of the tube and the bolus tip were missing, confirming the reported breakage.No occlusions were observed.However, the tube was observed to have formed a balloon shape where the breakage occurred.The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.As part of the investigation all processes and controls were reviewed and found to be correctly followed.There were no abnormal conditions found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported the 8fr ng tube tip broke off while in place.The mom noted resistance 1.5 weeks ago following administration of medication but was eventually able to flush the tube with water again.No further issues were noted by the family but upon ct scan review by radiologist on (b)(6), the tip of ng tube was seen in the small intestine.The patient has not yet passed the tip of ng tube but the remainder of the tube was removed in the clinic.Per additional information provided on 24nov2025, the ct scan was performed on (b)(6), not (b)(6) which was initially reported in error.This was a routine scan for monitoring purposes with regards to the patient's medical history.As of last thursday, the tip of the ng tube had not passed yet.Per further information provided on 02dec2025, as of (b)(6), the tip of the ng tube had still not passed.Per additional information provided on 11dec2025, the tip has not passed yet.The current plan as per surgery is to wait and let it pass on its own.
Event or Problem Description
The customer reported the 8fr ng tube tip broke off while in place.The mom noted resistance 1.5 weeks ago following administration of medication but was eventually able to flush the tube with water again.No further issues were noted by the family but upon ct scan review by radiologist on (b)(6), the tip of ng tube was seen in the small intestine.The patient has not yet passed the tip of ng tube but the remainder of the tube was removed in the clinic.Per additional information provided on 24nov2025, the ct scan was performed on (b)(6), not (b)(6) which was initially reported in error.This was a routine scan for monitoring purposes with regards to the patient's medical history.As of last thursday, the tip of the ng tube had not passed yet.Per further information provided on 02dec2025, as of (b)(6), the tip of the ng tube had still not passed.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 23638820
• Report Number: 1423537-2025-00477
• Device Sequence Number: 15731296
• Product Code: KNT
• UDI-Device Identifier: 10192253011654
• UDI-Public: (01)10192253011654
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2026

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/02/2025; 12/11/2025; 01/13/2026
• 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