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

Model Number 8884711253E

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: there is a crack between the lumens of the enteral tube, requiring replacement.

• 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: 12407355
• MDR Text Key: 270821741
• Report Number: 9612030-2021-03035
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 1926702664
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1