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

Model Number 8884711253E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the enfit connector loosened.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two photos were provided for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• Type of Device: 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: 16259331
• MDR Text Key: 308712773
• Report Number: 9612030-2023-03539
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

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: 2105403564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/20/2023
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1