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

Model Number 8884711253

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

The customer reported that when the physician was placing the nasogastric tube in the patient, when manipulating the stylet, the protective cap on the end of the stylet became disconnected and the physician received a puncture wound from the stylet.Per additional information received, they do not have photos or any further information regarding the event that occurred.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on july 08, 2021.The investigation was carried out with the multifunctional team, all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.There were no photos or physical samples received for investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.We will continue to monitor for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET
• 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: 15890178
• MDR Text Key: 307679139
• Report Number: 9612030-2022-03479
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2118704564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1