MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX NRFIT EPIDURAL CONTINUOUS PROC TRAY/KIT; ANESTHESIA CONDUCTION KIT

Catalog Number 24-1300-22

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that the catheter wouldn't advance when the epidural needle was sited, so the whole kit was removed.There was resistance on removal, and the tip of the catheter had sheared off inside the patient.There was unknown patient harm/adverse event reported.

Manufacturer Narrative

D4: lot number, expiration date and h4: manufacture date are unknown; no information has been provided to date.E1: initial reporter phone number: (b)(6).H3 : other: device has not been received to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

No device was received for investigation.Therefore, the reported complaint cannot be confirmed.If icu medical receives the device, the investigation will be reopened, and a supplemental report will be sent.It is possible that the failure was caused by customer due to incorrect practice but with lack of sample or more information the root cause of this failure remains unknown.A review of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: PORTEX NRFIT EPIDURAL CONTINUOUS PROC TRAY/KIT
• Type of Device: 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: 18588978
• MDR Text Key: 334836670
• Report Number: 3011237704-2024-00027
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 24-1300-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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