MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. REGIONAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number NCE6112JP

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that during use the epifuse connector was damaged.No patient injury or clinical affects was reported.

Manufacturer Narrative

Other, other text: d4: expiration date is unknown, no information is available based on reported lot number.D4: udi number is unknown, no information has been provided to date.One used (pre-use check) device was received without its original package.Visual inspection confirmed the complaint as the hinge part of epifuse connector was broken.The most probable root cause was due to the molding design of the product.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• Brand Name: REGIONAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17674609
• MDR Text Key: 322658012
• Report Number: 3012307300-2023-08664
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCE6112JP
• Device Lot Number: 230515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1