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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-VENT 2 STRAIGHT FLEX; CONDENSER, HEAT AND MOISTURE (ARTIFI
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TELEFLEX MEDICAL HUDSON HUMID-VENT 2 STRAIGHT FLEX; CONDENSER, HEAT AND MOISTURE (ARTIFI Back to Search Results
Catalog Number 17732
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "approximately 30 minutes into uneventful nasal septoplasty case with the patient's head turned 180 degrees away, the ventilator sounded an apnea alarm.(cont.) the culprit was found to be a clean "laceration" of the humid vent device at the junction of the hard plastic rim (connected to the endotracheal tube) and the first soft plastic ridge of the accordion tubing.Examination of the wrapper for this device showed no pre-existing cuts which might have compromised the device.The device worked fine for 30 minutes from its insertion.There was only an occasional surgeon's elbow near the humid-vent which was under sterile surgical drapes; no scalpel was near.This happened twice with two different patients." second event captured in mfr.Rpt.8040412-2018-00255.
 
Manufacturer Narrative
(b)(4).Catalog# corrected to 17732.The sample was not returned for evaluation.The complaint reports that there was "a clean "laceration" of the humid-vent device" and "the device worked fine for 30 minutes from its insertion." it is possible that mishandling of the product could cause the cut on the tube as it occurred during use.In the current manufacturing procedure 100% leak testing at the assembly area is conducted; thus, any defective product would be detected prior to release from the manufacturing facility.Ten pieces of the same product were taken from current production at the manufacturing facility and testing was conducted.All samples were assembled correctly and passed the leak test.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer complaint alleges "approximately 30 minutes into uneventful nasal septoplasty case with the patient's head turned 180 degrees away, the ventilator sounded an apnea alarm.The culprit was found to be a clean "laceration" of the humid vent device at the junction of the hard plastic rim (connected to the endotracheal tube) and the first soft plastic ridge of the accordion tubing.Examination of the wrapper for this device showed no pre-existing cuts which might have compromised the device.The device worked fine for 30 minutes from its insertion.There was only an occasional surgeon's elbow near the humid-vent which was under sterile surgical drapes; no scalpel was near.This happened twice with two different patients." second event captured in mfr.Rpt.8040412-2018-00256.
 
Manufacturer Narrative
(b)(4).Enrty in field b.5."second event captured in mfr.Rpt.8040412-2018-00255." corrected to read "second event captured in mfr.Rpt.8040412-2018-00256.".
 
Event Description
Customer complaint alleges "approximately 30 minutes into uneventful nasal septoplasty case with the patient's head turned 180 degrees away, the ventilator sounded an apnea alarm.(cont.) the culprit was found to be a clean "laceration" of the humid vent device at the junction of the hard plastic rim (connected to the endotracheal tube) and the first soft plastic ridge of the accordion tubing.Examination of the wrapper for this device showed no pre-existing cuts which might have compromised the device.The device worked fine for 30 minutes from its insertion.There was only an occasional surgeon's elbow near the humid-vent which was under sterile surgical drapes; no scalpel was near.This happened twice with two different patients." second event captured in mfr.Rpt.8040412-2018-00256.
 
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Brand Name
HUDSON HUMID-VENT 2 STRAIGHT FLEX
Type of Device
CONDENSER, HEAT AND MOISTURE (ARTIFI
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
MDR Report Key7890122
MDR Text Key120834127
Report Number8040412-2018-00254
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 08/27/2018
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 No Information
Device Catalogue Number17732
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/27/2018
Initial Date FDA Received09/19/2018
Supplement Dates Manufacturer Received08/27/2018
10/11/2018
Supplement Dates FDA Received09/19/2018
10/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENDOTRACHEAL TUBE; ENDOTRACHEAL TUBE; ENDOTRACHEAL TUBE
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