MAUDE Adverse Event Report: CARDINAL HEALTH ANG WING 23GA BCS W/BC HLDR; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Model Number	8881225265
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the needle remained in the patients arm and the nurse was able to remove it, so no harm was done and they are doing x-rays to be sure.The product was pulled off of the shelves, it is only used in the emergency room department.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Photographs were provided for analysis.Subsequently, one used sample was received for evaluation.An examination of the photographs confirmed that the cannula had fell off from the angel wing and the visual inspection of the used sample found the cannula detached from the angel wing.The root cause could be related to a manufacturing/production process due to a lack of glue between the cannula and the angel wing joint.Complaint trends are evaluated during a monthly meeting to determine if a formal corrective/preventative action (capa) is warranted.

• Brand Name: ANG WING 23GA BCS W/BC HLDR
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• 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 ; 5086183640
• MDR Report Key: 15470455
• Report Number: 1282497-2022-10718
• Device Sequence Number: 4688479
• Product Code: GIM
• UDI-Device Identifier: 20884521013282
• UDI-Public: 20884521013282
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8881225265
• Device Catalogue Number: 8881225265
• Device Lot Number: 212700352
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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