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

Catalog Number	5-15102
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported complaint issue of "detached - stylet" was confirmed based upon the sample received.The customer returned one unit 5-15102 stylet, sher-i-slip, pediatric for investigation.The customer also returned one non-tfx et tube (portex, size 2.5).The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the stylet 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 broken piece of the sheath was inside of the returned et tube.It appears that the sheath got stuck inside the tube and tore off once the stylet was pulled.The damaged stylet was measured with a ruler to see how much of the sheath broke off.The sheath was fully broken off from the stylet up to approximately 5 3/16" from the distal tip.The sheath was also partially sheared off an additional 13/16".The outer diameter of the returned stylet was measured with a digital caliper.According to required specifications, the stylet should have an o.D.Of 1.7mm.Multiple measurements were taken of the outer diameter where the stylet was still covering the wire and all measurements were between 1.64-1.70mm.There are no dimensional issues with the outer diameter of the stylet.The stylet wire seems to have been pulled forward since the sheath at the proximal end is no longer over the wire.Based on the observed damage, 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 found to be approximately 1.64-1.70mm for the broken stylet which is within the specifications.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 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 or Problem Description
It was reported that "i am reporting an issue with a stylet that was used in our unit where the blue sheath dislodged in the endotracheal tube during intubation".Additional information: during intubation of an infant the stylet came out without the plastic sheath, which stayed in the tube.The physician pulled out the endotracheal tube with the stylet plastic in it.The patients sats dropped to 40% for 20 seconds, they were bagged for 2 minutes to bring sats back up and then reintubated without issue.The patient was reported as "critical, but stable on a ventilator".There was no reported patient harm or consequence from the reported incident.

• Brand Name: STYLET,SHER-I-SLIP,PEDIATRIC
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18745663
• Report Number: 3003898360-2024-00231
• Device Sequence Number: 17950277
• Product Code: BSR
• UDI-Device Identifier: 04026704397525
• UDI-Public: 04026704397525
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2025
• Device Catalogue Number: 5-15102
• Device Lot Number: 73A2000592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.
• Patient Sex: Unknown