MAUDE Adverse Event Report: DEGANIA SILICONE LTD MEDLINE ENTRAFLO GASTROSTOMY FEEDING TUBE

Model Number 22FR

Device Problem Device Handling Problem (3265)

Patient Problem Gastritis (1874)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The actual sample from the customer's complaint reported to be unavailable.We did receive the picture of the actual device inside the patient, the picture was made during the gastroduodenoscopy procedure.Note: the lot number # 94505 provided by the initial reporter is not the lot of degania and does not look similar to lot numbers utilised by degania.The user indicated that gastric ulcer likely being caused from a protruding plastic device at the end of the peg tube, which is causing trauma to gastric mucosa.Degania's peg tube does not have plastic parts on its end; it is made from soft silicone material.The device on the picture provided by the customer does look like device produced by degania.However the balloon of the peg tube which holds the device inside of the patient on the picture looks to be inflated much less then it should be (15 cc).If the balloon is not inflated to its nominal volume, it causes the shaft's end to protrude more then when the balloon is fully inflated.The currently produced parts were inspected and found to be ok regarding their specification.We have no reasons to suggest that the device seen on the picture deviates from its specification.

Event Description

Initial notification from our customer medline inc.On 11.08.2017: "phone call placed to (b)(6), customer's wife, who reported that her husband, (b)(6), had a feeding tube put in (b)(6) 2016 (not a medline industries, inc.Tube).(b)(6) reported that in (b)(6) 2017 the stopper on the tube cracked and she had to have the tube replaced.(b)(6) stated that the doctor replaced the tube with a medline industries, inc.Tube and the patient was discharged.A week later, (b)(6) stated that she was checking (b)(6)'s residual and she extracted coffee ground residual.(b)(6) was taken to the hospital and underwent an esophagogastroduodenoscopy (egd) procedure where the surgeon discovered a gastric ulcer.According to the wife, the medline industries, inc.Balloon that holds the percutaneous endoscopic gastrostomy (peg) tube in place was not inflated and was rubbing against gastric mucosa which was causing the ulcer.The peg tube was replaced with a different tube without further incident.Due to the reported incident and subsequent need for medical intervention, this is an mdr reportable event.A sample is available and has been requested to be returned for evaluation." update from medline inc.On 11.17.2017: "we do not have a sample that can be sent for evaluation".The lot number # 94505 provided by medline is not degania's lot number and does not look like lot numbers utilized by degania.

• Brand Name: MEDLINE ENTRAFLO GASTROSTOMY FEEDING TUBE
• Type of Device: GASTROSTOMY FEEDING TUBE
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, jordan valley 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, jordan valley 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15130-00 ; IS 1513000
• MDR Report Key: 7116385
• MDR Text Key: 94805011
• Report Number: 8030107-2017-00002
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 22FR
• Device Catalogue Number: 103005002280MD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR