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

Catalog Number 5-15102

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 09/14/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4)."although a lot number was not reported, one potential lot number was found through the sales history.The potential lot number is 73l2100398.Per dhr the product stylet, sher-i-slip, pediatric lot # 73l2100398 was manufactured on 11/08/2021 a total of (b)(4) pieces.Lot was released on 11/18/2021.Dhr investigation did not show issues related to complaint.".

Event Description

It was reported that: premature baby, 5 hours old, was being orally intubated.A piece of plastic broke off from the stylet, it remained in the intubation tube and was removed with the tube.The patient was reintubated succesfully.There was no reported patient harm or consequence from the event and the patient was discharged home after a month.

Manufacturer Narrative

(b)(4).The reported complaint issue of "detached - stylet" was confirmed based upon the samples received.Two representative samples were returned in addition to the actual sample that caused this complaint issue.The damaged stylet was found to be missing part of its sheath at the distal end.The sheath was fully broken off of the stylet up to approximately 1 1/32" from the distal tip.The sheath was also partially sheared off up until approximately 3 5/8" from the distal tip.The part of the sheath that came off the stylet was not returned.The sheath was crinkled at the separation point of where it is fully sheared and partially sheared off.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.No damages were observed on the representative samples that were returned.The outer diameter was found to be approximately 1.74-1.97mm for all three devices which is within the specifications.Therefore, the stylet would not get trapped inside the et tube due to being too big for the tube if the proper size et tube was used.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 Description

It was reported that: premature baby, 5 hours old, was being orally intubated.A piece of plastic broke off from the stylet, it remained in the intubation tube and was removed with the tube.The patient was reintubated successfully.There was no reported patient harm or consequence from the event and the patient was discharged home after a month.

Manufacturer Narrative

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

Event Description

It was reported that: premature baby, 5 hours old, was being orally intubated.A piece of plastic broke off from the stylet, it remained in the intubation tube and was removed with the tube.The patient was reintubated successfully.There was no reported patient harm or consequence from the event and the patient was discharged home after a month.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18216823
• MDR Text Key: 329126955
• Report Number: 3003898360-2023-01514
• Device Sequence Number: 1
• Product Code: BSR
• UDI-Device Identifier: 04026704397525
• UDI-Public: 04026704397525
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2023

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 Catalogue Number: 5-15102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/01/2023; Not provided
• Supplement Dates FDA Received: 12/07/2023; 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG