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

Catalog Number	24-1302-22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
Event or Problem Description
It was reported that while siting the epidural for a woman in labor, the healthcare professional was unable to feed the catheter through the touey.Tried to rotate 180 degrees but still unable to feed catheter.Touey and catheter were removed, but while pulling back, a snap was felt.Tip of catheter had been sheared off.There was patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Codes: updated.Device evaluation: investigation of the reported complaint for "unable to feed catheter through touey and tried to rotate 180 degrees but still unable to feed catheter.Touey and catheter removed but as pulling back, felt a snap and the tip of the catheter had been sheared off" was limited because no sample, photo or video was provided for investigation.Based on the complaint description the catheter shred may have occurred because the customer did not follow instructions for use.Unfortunately, without the sample or photo we are unable to further assess this incident.There was no trend of similar customer complaints identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX NRFIT EPIDURAL CONTINUOUS MINIPACK TRAY
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21035947
• Report Number: 3011237704-2024-00278
• Device Sequence Number: 7631162
• Product Code: CAZ
• UDI-Device Identifier: 15019517075342
• UDI-Public: (01)15019517075342(17)280711(10)4386588
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 24-1302-22
• Device Lot Number: 4386588
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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 Age: 29 YR
• Patient Sex: Female