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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON STYLET,SOFT TIP,6 FR; STYLET, TRACHEAL TUBE
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TELEFLEX MEDICAL HUDSON STYLET,SOFT TIP,6 FR; STYLET, TRACHEAL TUBE Back to Search Results
Catalog Number 5-15120
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer complaint alleges "a piece of plastic was found in the mouth of a (b)(6) new-born baby while he had a big cough.According to doctors, this piece of plastic is a part of the stylet of the intubation tube.(continued) it's 4-5 cm length (see pic 2).The doctor who performed the action reported an unsusual resistance whilst he removed the stylet." customer submitted a photo for reference.The patient condition was reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-15120 stylet, soft tip, 6 fr for investigation.Only a piece of the stylet sheath was returned.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the sample appears to be used as there is biological material present on the sheath.The piece of the sheath that was returned is approximately 2.0 inches and is from the distal end of the stylet.The rest of the stylet was not returned.The outer diameter of the returned stylet was measured and there were no dimensional issues found.The reported complaint issue of "stylet broke/separated" was confirmed based upon the sample received.Only a piece of the distal end of the stylet sheath was returned that was approximately 2.0 inches in length.The rest of the stylet was not returned.Based on the observed damage, it appears that the stylet most likely got trapped inside the et tube and after pulling on the stylet, part of the sheath broke off due to the excess friction.The outer diameter was within specification; therefore, the stylet would not get trapped inside the et tube due to being too big for the tube.A device history record review was performed with no evidence to suggest a manufacturing related cause.Based on the observed damage, it was determined that operational context caused or contributed to this event.
 
Event Description
Customer complaint alleges " "a piece of plastic was found in the mouth of a 2 months new-born baby while he had a big cough.According to doctors, this piece of plastic is a part of the stylet of the intubation tube.(continued) it's 4-5 cm length (see pic 2).The doctor who performed the action reported an unsusual resistance whilst he removed the stylet." customer submitted a photo for reference.The patient condition was reported as fine.
 
Event Description
Customer complaint alleges " "a piece of plastic was found in the mouth of a 2 months new-born baby while he had a big cough.According to doctors, this piece of plastic is a part of the stylet of the intubation tube.(continued) it's 4-5 cm length (see pic 2).The doctor who performed the action reported an unsusual resistance whilst he removed the stylet." customer submitted a photo for reference.The patient condition was reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).Correction to section additional: additional manufacturer narrative in the first follow-up states that a dhr was performed; however, this was reported in error.The lot number was not provided by the customer; therefore, a dhr review could not be performed.
 
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Brand Name
HUDSON STYLET,SOFT TIP,6 FR
Type of Device
STYLET, TRACHEAL TUBE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8236972
MDR Text Key132776107
Report Number3003898360-2019-00063
Device Sequence Number1
Product Code BSR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 12/20/2018
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 Number5-15120
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Initial Date Manufacturer Received 12/20/2018
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer Received02/01/2019
02/06/2019
Supplement Dates FDA Received02/01/2019
02/06/2019
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
Patient Age2 MO
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