MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX CATHETERS SUCTIONPRO; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number Z110N-14

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Information was received the inline suction portion of a smiths medical portex suction catheter snapped and broke while in use with a patient.This resulted in a small laceration on the clinician's index finger, as well as a heart rate increase of the patient to 120s and sao2 decrease to 59 percent.The patent was manually bagged until sao2 increased into the 90s.Addiitonally, the rt called for a new inline suction part.No patient injury resulted.

• Brand Name: SMITHS MEDICAL PORTEX CATHETERS SUCTIONPRO
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road,; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9176419
• MDR Text Key: 161969683
• Report Number: 3012307300-2019-05536
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: 15019315058868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2019

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?: No
• Device Operator: No Information
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: Z110N-14
• Device Lot Number: 3828464
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention