MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC UNKNOWN; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we can see that the bolster is missing from the distal end of the device with small portions still attached to the tip of the tube.The tubing is discolored and the print is completely worn away.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.However, information provided by the user indicates that the peg tube was left in place for three years.The ifu states: "peg replacement is recommended every three months or at the discretion of the physician." the image of the device shows discoloration and a lack of print which is indicative of wear and age.The cause of this report is likely related to using the product beyond its intended life.The instruction for use also warns, "the bolster should sit close to the skin but not tight against the skin.Excessive traction on the tube may cause premature removal, fatigue, or failure of the device." prior to distribution, all peg 24 percutaneous endoscopic gastrostomy sets are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that the peg tube was left in place for three years, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During a feeding tube replacement, the physician used a cook peg tube [unknown model].It was reported [that] this patient has had this cook peg tube for 3 years.When dr.(b)(6) pulled the peg tube out he realized that part of it was missing.The balloon [bolster], which he had deflated, was left inside the stomach.He performed a gastroscopy to retrieve the balloon [bolster].A section of the device did not remain inside the patient¿s body.The detached portion of the peg tube was retrieved.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16673242
• MDR Text Key: 312600701
• Report Number: 1037905-2023-00151
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL.
• Patient Outcome(s): Required Intervention