MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7605-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after switching to electrodermal activity (eda) and spinal with nrfit connection, there have been a few incidents during eda laying where the hoses have been connected incorrectly, which has resulted in occlusion and pump alarms.It was stated that on the previous hoses, it had been clearly marked which connection should go to which as they have been able to think "color to color" (red to blue) and as all connections are now yellow, it will result in errors.In addition, the hoses are very long, the ones they had before were 113 cm, now they are significantly longer, 223 cm.There was patient involvement.No patient harm/adverse event was reported.
Additional Manufacturer Narrative
Neither samples nor pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.

• Brand Name: NRFIT CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20484624
• Report Number: 3012307300-2024-11455
• Device Sequence Number: 3553352
• Product Code: FPA
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162219
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 21-7605-24
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• 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