MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 43INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858E
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Clinical staff were attempting to place in a pediatric patient that had the end cap pull away from the guidewire.This occurred before the guidewire was placed in the patient.Per additional information provided by the customer on (b)(6) 2022, the cap detached from the guidewire leaving the sharp guidewire bent but sticking out from the tube.The tube was still intact and the stylet was unable to be removed.The hydromer coating was reactivated using approximately 10-15 ml of water before attempting the removal.
Additional Manufacturer Narrative
A review of the device history record (dhr)revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One sample was received for evaluation.The sample was visually checked according to product specifications.Only one (1) stylet was received with the disassembly of the hub, and a poly bag with the reported code.The hydromer test could not be done since the tube of the reported code was not received.The hub was disassembled from the wire however, hub detachment can be caused by not activating the hydromer with enough fluid.The reported condition is confirmed.A gemba walk though was done to review the manufacturing process.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.A corrective/preventative action plan is not required since the reported condition has not been identified as manufacturing related.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15640621
• Report Number: 9612030-2022-03434
• Device Sequence Number: 5715383
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2123100964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/09/2023
• 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