MAUDE Adverse Event Report: CARDINAL HEALTH 5146 PENROSE TUBE 1/4 IN; ACCESSORIES, CATHETER

Model Number 8888514604

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Customer reports: there is a small hole/crack in the penrose tubing located where the tube was bent inside the packaging.The drain appeared intact however the hole/crack was noticed once tension was applied to the drain.Once noticed, a new drain was requested which was inspected prior to giving to the surgeon.A few other packages also had this issue.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was discarded.

Manufacturer Narrative

A device history record (lot 210180099) review of the reported lot number was not possible as the provided lot number is invalid.One used sample was received for evaluation.A visual and functional inspection was performed, and a hole / break was visible in the piece.No root cause could be found related to a manufacturing/production process.This complaint will be used for tracking and trending purposes.

• Brand Name: 5146 PENROSE TUBE 1/4 IN
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17802742
• MDR Text Key: 324127223
• Report Number: 1282497-2023-10796
• 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,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888514604
• Device Catalogue Number: 8888514604
• Device Lot Number: 210180099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1