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

Model Number 8884721252

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

The customer reported when they went to remove the metal guide of the sne (naso tube) that had already been placed in the patient, the plastic tip came loose and the metal part (which looks like a hook) entered their finger.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Additional information: h4 device manufacture date added 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 condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.A walk through of the process was performed.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, quality inspections are performed to the product for material release.Production personnel perform a 100% visual inspection during the packaging process, in order to detect and discard any identified issues.The root cause could not be determined as the complaint was not confirmed.A risk assessment was performed showing the observed occurrence is below the range of the expected occurrence.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTFLX 12FR 43IN W STYL YPORT
• Type of Device: 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: 15369493
• MDR Text Key: 303403058
• Report Number: 9612030-2022-03378
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2204101164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Date Device Manufactured: 02/14/2022
• Type of Device Usage: A
• Patient Sequence Number: 1