MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 000

Model Number IPN055757

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Laceration(s) (1946); Insufficient Information (4580)

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "a report of lip injury to one baby w/ use of our blade by provider".Additional information received stated that "the [physician] intubated the patient and noticed the laryngoscope blade cut the baby's gum, no medical intervention performed".Additional information has been requested to the complainant, no information received at the time of this report.

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 customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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 Description

It was reported "a report of lip injury to one baby w/ use of our blade by provider".Additional information received stated that "the [physician] intubated the patient and noticed the laryngoscope blade cut the baby's gum, no medical intervention performed".Additional information has been requested to the complainant, no information received at the time of this report.

• Brand Name: RUSCH POLARIS FO BLADE MILLER 000
• Type of Device: POLARIS
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15833521
• MDR Text Key: 307745247
• Report Number: 3011137372-2022-00212
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704734358
• UDI-Public: 14026704734358
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN055757
• Device Catalogue Number: 4150003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NONE REPORTED; NONE REPORTED