MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR; DH EF BALLOON TUBES PRODUCTS

Model Number 8200-12LV

Device Problem Migration (4003)

Patient Problems Pain (1994); Tachycardia (2095); Sweating (2444); Increased Respiratory Rate (2486)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 09 mar 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

Fda medwatch / fda user facility report # (b)(4) received on 17-feb -2020, and the following information was provided: "describe the event or problem: patient had a jejunostomy tube (j-tube) requiring cardizem medication to be instilled at 0026, tube feeding machine was paused, what appeared to be "port" of tube feeding line had 20ml water flushed through, and half of crushed cardizem med in water was administered.Line began to get sluggish and then a pop sound occurred at this point patient complained of sharp pain.Doctor and charge nurse were notified doctor said to turn off tube feeding for the time being, and attempt instilling second half of cardizem medication at 0200 at 0200, the cardizem medication again would not go into the j-tube, and with just about 3ml of content administered the patient again complained of sharp pain, so i stopped all med administration i asked for a second opinion on the patient's status and notified the crisis nurse we changed the wound dressing at the site nurse assessment and mine also warranted notifying the doctor using the "i am concerned" statements, and doctor came to the bedside to also see how the patient was doing.The patient's belly looked slightly rounded at the site he was diaphoretic and had been all night, including now respirations were on the high end as was heart rate.Doctor put in an order for ct [computed tomography] and for a transfer to another floor after the ct was completed downstairs, the crisis nurse notified me that the j-tube had dislodged downstairs she showed me that what i had believed was a port for med administration may have actually been the balloon to keep the j-tube stable i was educated on the whole mechanism of the j-tube tubing and securement." device was approximately 3 months old.Additional information received on 21-feb-2020 indicated the "patient is still in hospital but does not have any issues because of the incident reported." patient weight was also provided.

Manufacturer Narrative

Additional information provided for b3: date of event.All information reasonably known as of 22 apr 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9809180
• MDR Text Key: 199138051
• Report Number: 9611594-2020-00042
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770445663
• UDI-Public: 00350770445663
• Combination Product (y/n): N
• PMA/PMN Number: K853197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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 Operator: Health Professional
• Device Model Number: 8200-12LV
• Device Catalogue Number: 104456600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/22/2020
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 77