MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253E
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the feeding tube was inserted april 12th, 2024.And confirmed by bedside cxr.The radiologist confirmed appropriate placement.Additional information received june 6, 2024: the nasogastric (ng) feeding tube was inserted (b)(6) 2024.Following chest x-ray (cxr), placement was confirmed by radiologist and intensivist.On (b)(6) 2024, the primary nurse noticed there was difficulty flushing the ng.The ng was removed and discovered to not be intact; the weighted tip was missing.The tube appeared ¿frayed¿.A cxr confirmed the weighted tip was still in the stomach.Initially the weighted tip was left for the patient to pass through her bowels naturally; however, on (b)(6) 2024, the weighed tip was removed by gastroscopy procedure.No specific injury to the patient was noted.Due to the product failure the patient required a second ng tube insertion, multiple additional x-rays to confirm placement of the new tube and to assess location of the missing weighted tip, and ultimately a gastroscopy procedure to remove the weighted tip.
Additional Manufacturer Narrative
D4 udi added.H4 device manufacture date added.H5 labeled for single use updated.H6 medical device problem code added.The device history record (dhr) review showed all inspection results were carried out and were within acceptable criteria as per established sampling plan levels and quality procedures.One decontaminated sample was received for evaluation.The sample was visually inspected, and it was observed that there was a break in the part of the tube near the bolus.A kind of balloon was created which thinned the walls of the tube and broke.The reported condition was confirmed.A walk through of the manufacturing process was performed.All process and controls were found properly followed.The instructions for use (ifu) provide information on care and use of the product.The root cause could not be determined with the available information.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• 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: 19477294
• Report Number: 9612030-2024-00083
• Device Sequence Number: 3931168
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: (01)10884521582927(17)281031(10)2332512364
• 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): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2332512364
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown