MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX NRFIT CONNECTOR EPIDURAL MINIPAK; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1301-22
Medical Device Problem Codes	Disconnection (1171); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after switching to the nrfit version of epidural minipack system, a disconnection occurred between the yellow clip holding the catheter and the bacterial filter within the first two weeks of use.It appears that the screw connection between the yellow clip holding the catheter and the bacterial filter in the nrfit version is not sufficiently secure.The event took place in the maternity unit, directly affecting the patient, resulting in failed pain relief during labor.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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.
Additional Manufacturer Narrative
The investigation of this complaint was carried out based on a video provided by the customer.In the video it was observed that when both components are assembled, the filter is easily pulled out and the rotating collar remains connected to yellow connector.Unfortunately, without the device sample we are unable to confirm or disprove if the securing ring was damaged.The root cause of the complaint is unknown.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: PORTEX NRFIT CONNECTOR EPIDURAL MINIPAK
• 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: 20599694
• Report Number: 3011237704-2024-00240
• Device Sequence Number: 8787452
• Product Code: CAZ
• UDI-Device Identifier: 15019517073935
• UDI-Public: (01)15019517073935
• 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): 12/23/2024

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: UNKNOWN
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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