MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the rn went to remove the guidewire from patient's ng tube when the purple cap of the guidewire came off.The wire underneath the purple cap was sharp and cut the rn's finger, resulting in a potential blood and body fluid exposure.The guidewire was still able to be removed after cap failure.The rn had to undergo bbfe protocols/treatment and started prophylactic medications.Per additional information provided on 22jun2026, bbfe (blood body fluid exposure) prophylaxis treatment is a standard treatment for potential exposure to bbfe.At this time, the staff was started on this treatment, harm level unknown.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25732517
• Report Number: 1423537-2026-00219
• Device Sequence Number: 21471159
• Product Code: KNT
• UDI-Device Identifier: 10192253011838
• UDI-Public: (01)10192253011838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• 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,Followup
• Report Date (Section B): 07/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 07/13/2026; 07/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown