MAUDE Adverse Event Report: AVANOS MEDICAL INC. TURBO-CLEANING CLOSED SUCTION CATHETER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 227-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 07 oct 2019 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 halyard health complaint database and identified as complaint (b)(4).

Event Description

It was reported that "a pt [patient] post extubation, coughed up sputum with a probable turbo closed suction piece.The turbo closed suction catheter was thrown away and therefore unable to be examined.The naso gastric tube was also removed and the tip checked and found to be intact.I asked if the ett [endotracheal tube] tube had been cut at any stage (a practice to reduce the length of the ett tube) and [hospital staff member] did not know and this subject had been discussed with the staff member looking after the pt.[hospital staff member] could not find out any other information regarding what happened at extubation prior to the pt coughing up the plastic.[hospital staff member] did not know if it was a size 12 turbo or size 14 turbo endotracheal suction catheter used.It is not known how long the turbo suction catheter had been insitu and there was no more information on how long the pt had been intubated etc.Hospital staff member is not 100% sure the plastic was from a suction catheter although it appears identical to the tip of the turbo." additional information received on 20-sep-2019 indicated that "evidently the nurse and physio attempted to suction the pt prior to extubation but could not initiate a cough so they disposed of the turbo csc [closed suction catheter] and replaced it with a new one to suction prior to extubation.Post intubation the pt coughed up sputum and the "plastic" ( looks like the end of the turbo).Staff then removed the ng [nasogastric tube] to see if the "plastic tip" was from the ng." further additional information received 20-sep-2019 stated "situation: patient extubated and immediately post extubation pt started coughing.Then pt coughed out what looked like the tip of an ngt (nasogastric tube).After pt settled and on examination of both ngt which i removed and the piece of plastic that the pt had coughed up i realised that it was not part of the ngt.Prior to extubation when i pulled back on the suction tube it pulled back right out of the ett into the suction tube.The same thing happened when the physio tried to suction so i changed the inline suction catheter.When the piece of plastic was compared to an inline suction tube it looked like this not a ngt.Action: patient not harmed in incident, informed doctor and cns [clinical nurse specialist].Suction catheter removed.Only part of the closed suction plastic was kept, the remainder including packing was no longer able to be found.We suspect the plastic came from a closed suction systerm 14french ett." additional information received on 30-sep-2019 included patient related information.

Manufacturer Narrative

The device was evaluated.The failure was confirmed.The root cause was incorrect use.Based on the sample evaluation, component had marks on the edge which indicated that it was cut by user.Also, the black mark in the part indicated that catheter was not fully retracted before the cut.This failure was caused due to incorrect use of device by the user.All information reasonably known as of (b)(6) 2019 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 halyard health 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.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 16-nov-2019 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 halyard health 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: TURBO-CLEANING CLOSED SUCTION CATHETER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9166261
• MDR Text Key: 203318810
• Report Number: 8030647-2019-00091
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

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: 227-5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 11/25/2019
• Supplement Dates FDA Received: 11/18/2019; 12/20/2019
• Patient Sequence Number: 1
• Patient Age: 20 YR