AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR - ENDOSCOPIC/RAD,18FR; DH EF BALLOON TUBES PRODUCTS
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Model Number 8250-18 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 9611594-2022-00067 for the second event.Refer to 9611594-2022-00068 for the third event.It was reported there was an issue where the label was rubbing off of the g-j tube(ie: gastric and jejunal labels rubbing off actual tubing).There was a report of medications being put down the wrong port.There was no reported injury.Additional information received 28-apr-2022 stating it was reported by nursing that the label rubbed off sooner than this and tape was put on to help identify the tubes, the date of exact rubbing off is unknown.No medical intervention was required.
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Manufacturer Narrative
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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 18-may-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
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Manufacturer Narrative
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Correction:d1, d4 and g4.Additional information: b5.All information reasonably known as of 13-jun-2022 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.
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Event Description
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Additional information received 24-may-2022 regarding stoma/tube care information as follows: 1) wound cleanser is used on the stoma site only ¿ 1x a day nursing is instructed to clean the stoma site and replace a dry dressing over.We do not routinely clean the feeding tube itself unless it is visibly soiled (ie with bodily fluids, etc ¿ in which case we would also use wound cleanser.This does not happen often.) 2) site care ¿ stoma care ¿ is performed every day and each time the stoma is 'soiled' or becomes wet from perspiration/sweat, showering, etc.3) per report from our nutritionist, the tube was in place less than '6-weeks before the labels wore off.'.
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