MAUDE Adverse Event Report: CARDINAL HEALTH ANG WNG 25G BCS W/LUER ADPTR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225315
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the slide would fall apart when pushed.Per additional information received, the customer stated when the package was opened, the "butterfly" fell apart.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number unavailable.Because the sample was not provided for evaluation, the failure mode could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: ANG WNG 25G BCS W/LUER ADPTR
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183840
• MDR Report Key: 13259212
• Report Number: 1282497-2022-10673
• Device Sequence Number: 16569262
• Product Code: FOZ
• UDI-Device Identifier: 10884521013438
• UDI-Public: 10884521013438
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 8881225315
• Device Catalogue Number: 8881225315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown