MAUDE Adverse Event Report: CARDINAL HEALTH 5156 PENROSE TUBE 3/4 IN; ACCESSORIES, CATHETER

Model Number 8888515601

Device Problem Break (1069)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received the item cut in half.There was no patient injury reported.

• Brand Name: 5156 PENROSE TUBE 3/4 IN
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18768224
• MDR Text Key: 336119267
• Report Number: 9611018-2024-00011
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888515601
• Device Catalogue Number: 8888515601
• Device Lot Number: 201000015
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1