MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CLEANSWEEP ADULT, ENDOTRACHEAL, 14 FR; CATHETERS, SUCTION, TRACHEOBRO

Catalog Number 7214CS-LMR

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received by the manufacturer.However, the investigation of said device is still in progress.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges "cleansweep button not working properly - balloon would stay inflated and not deflate.Caused leak on the patient and patient wasn't getting her volumes because balloon was inflated in stuck in the one way valve." it was reported there was no patient injury or consequence.

Event Description

Customer complaint alleges "cleansweep button not working properly - balloon would stay inflated and not deflate.Caused leak on the patient and patient wasn't getting her volumes because balloon was inflated in stuck in the one way valve." (continued) it was reported there was no patient injury or consequence.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit 7214cs-lmr adult, endotracheal, 14 french, 72 hr for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed that the returned sample appears used as there is biological material present on the device.Functional inspection was performed on the sample to attempt to inflate and deflate the balloon.However, it was found that the thumb control valve was damaged which would prevent the balloon from properly inflating and deflating.The damage found to the thumb control valve indicates that the user tried to inflate the balloon when the valve was in the suction only mode (no balloon).The valve will stop short of pressing all the way in when in this mode.It appears that the end user forced the valve down after it reached its stopping point which damaged the valve.It is important to confirm that the control valve is in the correct position for balloon inflation/deflation.The ifu for this product states "it is important to confirm that the position of the control valve matches with the mode that is wanted.When perpendicular to the device, the control valve is in the "locked (off) mode".The image on the distal end of the control valve (pointing to the patient when parallel to the device) indicates whether the device is in "suction only mode" or "balloon + suction mode".The reported complaint of "balloon would not deflate during use" was confirmed based upon the sample received.It was found that the thumb control valve was damaged which would prevent the balloon from properly inflating and deflating.The damage found to the thumb control valve indicates that the user tried to inflate the balloon when the valve was in the suction only mode (no balloon).The valve will stop short of pressing all the way in when in this mode.It appears that the end user forced the valve down after it reached its stopping point which damaged the valve.It is important to confirm that the control valve is in the correct position for balloon inflation/deflation.Based on the damage observed and the condition of the returned et tube, it appears that the end user unintentionally caused or contributed to this event.

• Brand Name: HUDSON CLEANSWEEP ADULT, ENDOTRACHEAL, 14 FR
• Type of Device: CATHETERS, SUCTION, TRACHEOBRO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8310282
• MDR Text Key: 135877111
• Report Number: 3011137372-2019-00041
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7214CS-LMR
• Device Lot Number: 180800837A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.