MAUDE Adverse Event Report: TELEFLEX MEDICAL STYLET,SHER-I-SLIP,PEDIATRIC; STYLET, TRACHEAL TUBE

Model Number IPN048988

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that: "after an attempt at intrabronchial foreign body extraction in an 11-month-old infant, the infant was intubated for further intensive care unit therapy.Intubation initially went smoothly.When the stylet was withdrawn, it quickly became apparent that a large segment of the blue sheath of the stylet was dislocated.The tube was removed immediately.The new intubation - this time without the stylet - went smoothly.We then opened the tube where the event had occurred and were able to retrieve an 18.5 cm long plastic segment.Additional information: there was no part of the stylet left in the patient.There was no desaturation during the issue.The et tube with the segment of the dislocated stylet was removed within 5 seconds.There was no harm to the patient who was recovered and discharged.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The reported complaint issue of "detached - stylet" was confirmed based upon the samples received.The customer returned two units 5-15102 stylet, sher-i-slip, pediatric for investigation.One of the returned samples was a representative sample.Additionally, the customer returned one non-tfx et tube.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the stylet that caused this issue was missing part of its sheath at the distal end.Part of the sheath was broken completely off and part of it had a layer sheared off.The stylet wire seems to have been pulled forward wince the sheath at the proximal end no longer is over the wire.It appears that the sheath got stuck inside the tube and tore off once the stylet was pulled.The piece of sheath that broke off was also returned.The representative sample was undamaged in its original packaging.The damaged stylet was measured with a ruler to see how much of the sheath broke off.The sheath was fully broken from the stylet up to approximately 8 1/4" from the distal tip.The sheath was also partially sheared off up until approximately 8 13/16" from the distal tip.The outer diameter of the returned stylet was measured with a digital caliper.The stylet should be used in tracheal tubes of 2.5-4.5mm with an o.D.Of 2mm as per the product graphic.Multiple measurements were taken of the outer diameter where the stylet was still covering the wire all measurements were between 1.77-1.98mm.There are no dimensional issues with the outer diameter of the stylet.A device history record review was performed, and no relevant findings were identified.Based on the observed damage, it appears that unintentional user error caused or contributed to this event.However, it could not be determined exactly how or why this occurred.Teleflex will continue to monitor and trend on this complaint issue.

Event Description

It was reported that: "after an attempt at intrabronchial foreign body extraction in an 11-month-old infant, the infant was intubated for further intensive care unit therapy.Intubation initially went smoothly.When the stylet was withdrawn, it quickly became apparent that a large segment of the blue sheath of the stylet was dislocated.The tube was removed immediately.The new intubation - this time without the stylet - went smoothly.We then opened the tube where the event had occurred and were able to retrieve an 18.5 cm long plastic segment.Additional information: there was no part of the stylet left in the patient.There was no desaturation during the issue.The et tube with the segment of the dislocated stylet was removed within 5 seconds.There was no harm to the patient who was recovered and discharged.

Event Description

It was reported that: "after an attempt at intrabronchial foreign body extraction in an 11-month-old infant, the infant was intubated for further intensive care unit therapy.Intubation initially went smoothly.When the stylet was withdrawn, it quickly became apparent that a large segment of the blue sheath of the stylet was dislocated.The tube was removed immediately.The new intubation - this time without the stylet - went smoothly.We then opened the tube where the event had occurred and were able to retrieve an 18.5 cm long plastic segment.Additional information: there was no part of the stylet left in the patient.There was no desaturation during the issue.The et tube with the segment of the dislocated stylet was removed within 5 seconds.There was no harm to the patient who was recovered and discharged.

Manufacturer Narrative

Qn# (b)(4).Additional information received on 20nov2023 reported that the infant had a small stone deep in the upper lobe bronchus, which could not be mobilized for 90 minutes.The foreign body was removed 3 days later after intermittent administration of antibiotics and corticoids.For this procedure high frequency jet ventilation was alternated and ventilation through a rigid tube was performed.Due to the multiple passages of the glottis with the rigid tube and the need to repeatedly relax the child, the decision was made at the end of the intervention to perform post ventilation.There was no harm or damage to the patient.There was no desaturation to the patient as a mask was used for intermediate ventilation after removal of the first tube.The patient was cured and discharged.The reported complaint issue of "detached - stylet" was confirmed based upon the samples received.The customer returned two units 5-15102 stylet, sher-i-slip, pediatric for investigation.One of the returned samples was a representative sample.Additionally, the customer returned one non-tfx et tube.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the stylet that caused this issue was missing part of its sheath at the distal end.Part of the sheath was broken completely off and part of it had a layer sheared off.The stylet wire seems to have been pulled forward wince the sheath at the proximal end no longer is over the wire.It appears that the sheath got stuck inside the tube and tore off once the stylet was pulled.The piece of sheath that broke off was also returned.The representative sample was undamaged in its original packaging.The damaged stylet was measured with a ruler to see how much of the sheath broke off.The sheath was fully broken from the stylet up to approximately 8 1/4" from the distal tip.The sheath was also partially sheared off up until approximately 8 13/16" from the distal tip.The outer diameter of the returned stylet was measured with a digital caliper.The stylet should be used in tracheal tubes of 2.5-4.5mm with an o.D.Of 2mm as per the product graphic.Multiple measurements were taken of the outer diameter where the stylet was still covering the wire all measurements were between 1.77-1.98mm.There are no dimensional issues with the outer diameter of the stylet.A device history record review was performed, and no relevant findings were identified.Based on the observed damage, it appears that unintentional user error caused or contributed to this event.However, it could not be determined exactly how or why this occurred.Teleflex will continue to monitor and trend on this complaint issue.

Manufacturer Narrative

Qn# (b)(4).Correction: section d4 was updated from (b)(4).

Event Description

It was reported that: "after an attempt at intrabronchial foreign body extraction in an 11-month-old infant, the infant was intubated for further intensive care unit therapy.Intubation initially went smoothly.When the stylet was withdrawn, it quickly became apparent that a large segment of the blue sheath of the stylet was dislocated.The tube was removed immediately.The new intubation - this time without the stylet - went smoothly.We then opened the tube where the event had occurred and were able to retrieve an 18.5 cm long plastic segment.Additional information: there was no part of the stylet left in the patient.There was no desaturation during the issue.The et tube with the segment of the dislocated stylet was removed within 5 seconds.There was no harm to the patient who was recovered and discharged.

• Brand Name: STYLET,SHER-I-SLIP,PEDIATRIC
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18289552
• MDR Text Key: 329993292
• Report Number: 3003898360-2023-01545
• Device Sequence Number: 1
• Product Code: BSR
• UDI-Device Identifier: 04026704397525
• UDI-Public: 04026704397525
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2023

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: IPN048988
• Device Catalogue Number: 5-15102
• Device Lot Number: 73B2200803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 12/20/2023; Not provided
• Supplement Dates FDA Received: 12/21/2023; 12/21/2023; 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Age: 11 MO
• Patient Sex: Female