MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SWIVEL CONNECTOR REUSABLE 15MM; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/250/001

Device Problems Component Incompatible (1108); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Information was received that a smiths medical swivel connector was noted to be leaking.

• Brand Name: SMITHS MEDICAL SWIVEL CONNECTOR REUSABLE 15MM
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL, ASD INC. MHYT; boundary road; kent, hythe ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8510839
• MDR Text Key: 141810049
• Report Number: 3012307300-2019-01972
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 100/250/001
• Device Lot Number: 3509428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2017
• 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