MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN STYLET,SHER-I-SLIP,PEDIATRIC, 5FR; STYLET, TRACHEAL TUBE

Model Number	IPN044847
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports a verification of failure mode reported in the current manufacturing process was conducted as follows: 80 samples were taken from the current production; the samples were visually inspected, and issue reported detached - stylet was not observed in the current manufacturing process.A device history record review was also performed , and no relevant findings were identified.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 or Problem Description
Reported issue: plastic coating of stylet detached from stylet when stylet removed from endotracheal tube after intubation.10 cm piece of plastic coating remained in ett which was in infant's esophagus.Infant electively extubated due to the plastic piece in original ett and reintubated.No reported injury.

• Brand Name: SHERIDAN STYLET,SHER-I-SLIP,PEDIATRIC, 5FR
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16479435
• Report Number: 3003898360-2023-00311
• Device Sequence Number: 14240524
• Product Code: BSR
• UDI-Device Identifier: 04026704397525
• UDI-Public: 04026704397525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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: 06/28/2026
• Device Model Number: IPN044847
• Device Catalogue Number: 5-15102
• Device Lot Number: 73F2100932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Patient Race: American Indian Or Alaskan Native