MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX LOCAL ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT

Catalog Number NCE6126JP

Device Problem Failure to Disconnect (2541)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: month and year known; day of event is unknown.D4: lot number, expiration date, h4: manufacture date and g4: 510k number unknown.E1: (b)(6).One device was received for investigation.The device was visually inspected and functionally tested.The connection came off immediately after decontamination.Although it looked slightly white in appearance, no abnormalities such as deformation were observed.After fitting the reference connector, it was confirmed that both the epidural needle and glass syringe could be connected.The root cause could not be clearly identified but could potentially be use error as the device worked properly.A review of the device history records could not be completed as no lot number was provided by the customer.

Event Description

It was reported that the glass syringe and epidural needle were harder to dislodge than those normally used.No patient harm/adverse event reported.

• Brand Name: PORTEX LOCAL ANESTHESIA KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 18847607
• MDR Text Key: 337328460
• Report Number: 3012307300-2024-01163
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: NCE6126JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1