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

Model Number	8884711253E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Event or Problem Description
Customer reports: when changing the sne tube, the nursing technician observes that nasoenteral probe is cracked.Per additional information provided on 3/27/23, the crack & detachment is at the y-connector, the device was removed & replaced.
Additional Manufacturer Narrative
The device history record (dhr) for the reports lots were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.Three photographs were provided for evaluation.Based on the photo sample evaluation, the broken y port is observed.The reported issue is confirmed.A review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.An improvement opportunity was detected on the product design.A formal corrective/preventative action (capa) was created to address the reported condition and to identify improvement opportunities to the product design.The capa will modify the design and assembly process of the enfit y-port assembly.This design modification will include modifying the current molds for the enfit connector and y-port body to change the device from a winged enfit connector and y-port body design to a no-wing design.

• 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: 16657181
• Report Number: 9612030-2023-03661
• Device Sequence Number: 7172281
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2119403164
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown