MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NRFIT EPIDURAL NEEDLES, PORTEX NRFIT SPINAL; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed air was unable to be released from the flat filter.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Observation of the appearance of the returned product revealed no abnormalities leading to reported events such as deformation or breakage.The inside of the filter was found with liquid and air.It was difficult to flow when water was injected, but it was confirmed that it could be injected without problems if it was filled with water after sucking air.The tip of the filter was closed and pressure was applied, but no leakage was observed.The root cause of the reported issue could not be confirmed.The manufacture will be notified of the occurrence of this event and record the event in a database to monitor for future occurrence status.No additional information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX NRFIT EPIDURAL NEEDLES, PORTEX NRFIT SPINAL
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12 kitanagase-omotemachi,; minneapolis, MN 55442
• MDR Report Key: 15323185
• MDR Text Key: 305258354
• Report Number: 3012307300-2022-16859
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1