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

Model Number	8888514604
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Customer reports: there is a small hole/crack in the penrose tubing located where the tube was bent inside the packaging.
Additional Manufacturer Narrative
The device history record (lot 163300282) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.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
• Common Device Name: 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: 17804132
• Report Number: 1282497-2023-10797
• Device Sequence Number: 6858900
• Product Code: KGZ
• UDI-Device Identifier: 00884521149161
• UDI-Public: 00884521149161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 8888514604
• Device Catalogue Number: 8888514604
• Device Lot Number: 163300282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown