MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX LARYNGOSCOPE BLADES INTUBATION; LARYNGOSCOPE, RIGID

Catalog Number 2970.150.20

Device Problem Fracture (1260)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the green lid and spring damaged.This occurred during priming.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

One device was received.Visual inspection confirmed that the blade fixing ball and spring have fallen off.The cause was unknown.The device history record (dhr) is at the supplier and not readily available for review.The product was returned to the customer as unrepairable because no replacement parts were available.

• Brand Name: PORTEX LARYNGOSCOPE BLADES INTUBATION
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19069844
• MDR Text Key: 339688451
• Report Number: 3012307300-2024-02288
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: 2970.150.20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2024
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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