MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) PRODUCT CODE: OFP

Model Number 482802-NL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Information was received that during the use of a smiths medical portex pediatric disposable anesthesia breathing circuits the bag detached from black cap and was unable to continue use.Bag replaced with new on and ventilation was continued.No adverse patient effects were reported.

• Brand Name: PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) PRODUCT CODE: OFP
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4,; parque industrialinternacional; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9772856
• MDR Text Key: 181656366
• Report Number: 3012307300-2020-01631
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/17/2021
• Device Model Number: 482802-NL
• Device Lot Number: 3739563
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention