MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR;43IN W/STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that when going to take off the stylet, the stylet tip falls off.The nurse was punctured and bled.The nurse reported it to employee health.No actions needed as the patient did not have an active gi bleed therefore it was not considered an exposure.No treatment needed.
Additional Manufacturer Narrative
On 29-sep-2021 the facility stated that the sample was lost and will not be sent for evaluation.The facility also provided the lot number of the affected device and stated that no additional information is known.Based on the provided lot number, it was determined that the product number was reported incorrectly on the initial report.This report is being sent to correct the following information: d1 brand name; d3 manufacturer name, city and state; d4 model number; d4 catalog number; d4 lot number, d4 unique identifier (udi);g1 manufacturing site name and address.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana MA 22500 ; MX 22500
• MDR Report Key: 12530510
• Report Number: 1282497-2021-10629
• Device Sequence Number: 4230939
• Product Code: KNT
• UDI-Device Identifier: 10884521146136
• UDI-Public: 10884521146136
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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: No Information
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 1933713764
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1