MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1301-22
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer. a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was great difficulty in inserting the eda catheter even though the needle was correctly positioned in the back.The anesthesiologist had to stab the patient¿s back several times and with several eda catheter sets before the patient could get a functioning eda.This had happened on several occasions with different doctors and patients.The event date is unknown.There was patient involvement.No further information could be provided about the other lot numbers used as the products were thrown away.There was no human harm.The patient was stung several times and this led to a longer period until the patient received the medicine.
Additional Manufacturer Narrative
G2 - report source: corrected.H6.Codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20863984
• Report Number: 3011237704-2024-00270
• Device Sequence Number: 8839327
• Product Code: CAZ
• UDI-Device Identifier: 15019517073935
• UDI-Public: (01)15019517073935(17)290417(10)6008307
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 24-1301-22
• Device Lot Number: 6008307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown