MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 36INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when attempting to remove the stylet, the green cap became disconnected from it.The nurse's skin was punctured by the exposed wire that remained in the tube.According to the nurse, the tube was flushed prior to attempting to remove the stylet.
Additional Manufacturer Narrative
Other selected for no sample return because the product was discarded.An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported defect from customer complaint.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product sample was not provided for evaluation therefore the reported condition could not be confirmed.The root cause and corrective actions could not be identified without a sample evaluation however, the potential cause of the reported condition most likely occurred if there was a failure to activate the hydromer making it difficult to remove the stylet from the feeding tube.Please refer to the instructions for use (ifu) for the proper procedure for insertion of the feed tube and extraction of the stylet which reads: "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating.¿ based on the analysis, the observed occurrence of harm (o) is (1, improbable) which is equal the range of the expected occurrence of harm (o) (4, improbable).

• Brand Name: ENTRFLX 8FR 36INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 14053410
• Report Number: 9612030-2022-03216
• Device Sequence Number: 19994150
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/16/2022

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: 8884720825E
• Device Catalogue Number: 8884720825E
• Device Lot Number: 2119403264
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/16/2022
• 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