MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDERITE SINGLE- USE STYLET - SMALL; LARYNGOSCOPE, RIGID

Model Number 0803-0118

Device Problem Break (1069)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

9 month-old female received in emergency room from outlying rural clinic with past-medical history of recurring urinary tract infection (uti) due to anatomical abnormality: transferred here due to respiratory arrest, sepsis after being sick several days with fever and sick symptoms - sats 70% at room air.Placement of intraosseous access device (io) for labs.Patient coded - appx 25-minutes of cardiopulmonary resuscitation (cpr).At first attempt of intubation - the stylet for glidescope malfunctioned (snapped) prompting a repeat attempt with different tube & stylet.Patient was bagged between attempts with no difficulty and she never desaturated.Patient was successfully intubated, return of spontaneous circulation (rosc) and transferred to pediatric intensive care unit (picu).The respiratory therapist (rt) team notes this breakage has been happening recently - so there were 5 gliderites of this same ref & lot numbers pulled from ed after making sure there were other replacement items for use.In addition, there were 3 other gliderites pulled (with different ref & lot numbers) out of precaution.Unfortunately we have no data on the other patients with whom this similar event took place.Additionally to note: the initial device was not retained but it is noted that it is of the ref 0803-0118, lot gs 77314.

• Brand Name: GLIDERITE SINGLE- USE STYLET - SMALL
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 20001 n creek pkwy; bothell WA 98011
• MDR Report Key: 15635752
• MDR Text Key: 302054945
• Report Number: 15635752
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2022

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: 0803-0118
• Device Catalogue Number: 0803-0118
• Device Lot Number: GS77314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 270 DA
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Race: White