MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX SPINAL EPIDURAL CUSTOM TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number A3169-17/27

Device Problems Difficult to Flush (1251); Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Event Description

Information was received indicating that the catheter to a smiths medical portex spinal epidural custom tray was noted to have a hole about 6 inches proximal to the connector.The clinician had been called to the patient's bedside to give a bolus when the hole was found and that it had leaked onto the patient's bed.The clinician had stated that earlier that day, the catheter was unable to be flushed through the yellow connector.The yellow connector was reopened and then successfully flushed.There were no reported adverse patient effects.

• Brand Name: PORTEX SPINAL EPIDURAL CUSTOM TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8319078
• MDR Text Key: 135509730
• Report Number: 3012307300-2019-00629
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517142693
• UDI-Public: 15019517142693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E332605
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: A3169-17/27
• Device Lot Number: 3672362
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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