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 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the balloon would not deflate completely when attempting to suction the patient.The user was unable to pass the catheter into the airway.A new device was used for suctioning.No patient harm reported.Patient condition reported as "fine".

Event Description

Customer reported the balloon would not deflate completely when attempting to suction the patient.The user was unable to pass the c atheter into the airway.A new device was used for suctioning.No patient harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit 7214cs-lmr adult, endotracheal, 14 french, 72 hr for investigation.The returned sample was reviewed with a r & d engineer.The sample was visually examined with and without magnification.Visual examination revealed that the returned sample was returned with its balloon partially inflated and was missing the patient end sub-assembly that connects the cleansweep to the et tube.Functional inspection was performed on the device with a r & d engineer.First, the thumb control valve was set to "balloon + suction mode" and an attempt to inflate and deflate the balloon was made.The balloon was able to properly inflate, but was unable to deflate completely.However, according to r & d, the cleansweep device needs to be hooked up to a suction device in order for the balloon to be able to completely deflate.The cleansweep was hooked up to a suction line, vacuum pressure regulator, and med-vac canister.When the thumb control valve is pressed while the device is hooked up to suction/vacuum, the outer balloon deflates completely.The catheter was able to pass through a size 8.0 et tube with no issues while hooked up to a suction device.A leak was found in the inner balloon since that balloon was not inflating completely.The proximal end of the catheter was placed under water.Upon inflation of the balloon, it was confirmed that air was escaping through the inner balloon.It could not be determined what caused this leak to occur.It's possible that the excessive force was applied to the balloon when trying to insert it into the et tube, but this could not be confirmed.The supplier was consulted and confirmed that 100% of cleansweeps are tested for proper inflation/deflation at the time of manufacturing.It is unlikely that this leak was present at the time of manufacturing.The reported complaint of "balloon would not deflate" was not confirmed based upon the sample received.The returned sample was reviewed with a r & d engineer.The balloon was able to properly deflate once connected to a suction device and was able to pass through a size 8.0 et tube with no issues.However, a leak was found in the inner balloon.It could not be determined what caused this leak to occur.The supplier was consulted and confirmed that 100% of cleansweeps are tested for proper inflation/deflation at the time of manufacturing.It is unlikely that this leak was present at the time of manufacturing.We will continue to monitor and trend on this issue.

• Brand Name: HUDSON CLEANSWEEP ADULT, ENDOTRACHEAL, 14 FR
• Type of Device: CATHETERS, SUCTION, TRACHEOBRO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9432420
• MDR Text Key: 190847554
• Report Number: 3011137372-2019-00401
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.