MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CHEMOPLUS; CONTAINER, I.V.

Model Number	CP3002B
Medical Device Problem Codes	Material Puncture/Hole (1504); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there's a hole puncture in the back of the item.Medical intervention was not required.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Per additional information received, the customer does not believe that there is an actual issue because they have always received this item with holes in the packaging.Their inventory control team has made them aware that this is how each item looks in every shipment that they normally get.
Additional Manufacturer Narrative
A review of the device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.All dhrs are reviewed and approved by quality prior to release of product.Photos of the issue as described by the customer were provided.A review of the photos returned shows that the ¿holes¿ indicated are the vent holes required during production.There are two (2) sets of vent holes in the clear plastic bag using a 1/8 inch or smaller hole punch.From a root cause analysis perspective, the product was manufactured correctly with the required vent holes in the plastic wrap around the clamshell holder.The results of the investigation revealed no issues associated with the manufacturing of the product.There are no corrective or preventative actions necessary.Corrected h6 from 1504 to 3189.

• Brand Name: CHEMOPLUS
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21047728
• Report Number: 1423537-2024-00363
• Device Sequence Number: 16996548
• Product Code: KPE
• UDI-Device Identifier: 10884527005697
• UDI-Public: 10884527005697
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: CP3002B
• Device Catalogue Number: CP3002B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/14/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown