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

Model Number 8884711253E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The nursing staff reports that the nasoenteral probe is cracked and leaking.

Manufacturer Narrative

The device history record (dhr) could not be performed since no lot number was provided from customer complaint report, and no photo sample/actual sample with lot number was received.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue or related it to a manufacturing process.All associated lot documentation was carefully reviewed; no issues or discrepancies were found related to the reported complaint.Although a definitive root cause could not be determined, as per the instructions for use (ifu) clogging may occur if excessive force is applied when attempting to remove the connector cap with a twist, the y-port has an internal winged design that serves as a lever, causing a fissure from the y-port union.Therefore, an improvement opportunity was detected in the y-port design, this design modification will include the modification of the current molds for the enfit connector and y-port body to change from a ¿winged¿ enfit connector and y-port body design to a ¿no-wing¿ design.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET EN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13542607
• MDR Text Key: 285698436
• Report Number: 9612030-2022-03165
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1