MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC SINGLE LIMB DISPOSABLE CIRCUIT; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number 100/905/300

Device Problems Failure to Align (2522); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign - report source: (b)(6).

Event Description

Information was received that during the use of a smiths medical pneupac single limb disposable circuit, the endotracheal tube of an unknown brand got disconnected from the respiratory circuit connector.There were no adverse patient effects.

• Brand Name: PNEUPAC SINGLE LIMB DISPOSABLE CIRCUIT
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8965650
• MDR Text Key: 156619601
• Report Number: 3012307300-2019-04609
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/05/2019

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: No Information
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: 100/905/300
• Device Lot Number: 180730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2018
• 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