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

Model Number 8884711253

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

The customer reported the protective cover for handling the guide wire (cap) came loose in the package.

Manufacturer Narrative

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

Manufacturer Narrative

H4 device manufacturer date added evaluation summary: the device history record (dhr) review showed manufacturing and inspection of the product were performed as per applicable procedures and validated processes.A visual and functional inspection is performed for each batch prior to product release.A sample evaluation could not be performed because no sample nor photo was provided.The condition reported could not be confirmed.The root cause could not be determined without a sample to evaluate.No action plan is required at this point.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEAALTH; 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: 16725987
• MDR Text Key: 313152135
• Report Number: 9612030-2023-03673
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• 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: 06/22/2023

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: 2129203764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 06/22/2023
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1