MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL CUSTOM SINGLE SHOT TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number	A3797-24
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spinal needles are getting stuck in the introducer.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One opened but unused introducer needle product was received.Visual and functional testing were performed.Visual inspection found that the introducer needle with the unaided eye, did not reveal any visible defects or anomalies.However, visual inspection (with magnification) showed the inside diameter (id) at the hub of the introducer needle, to be slightly misaligned with the cannula.Functional testing confirmed the complaint.A supplier notification was previously issued to the supplier for the same introducer needle lot number.The finished good from this complaint was manufactured prior to this action.Therefore, this issue has already been addressed through the appropriate channels and no further actions will be taken at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX SPINAL CUSTOM SINGLE SHOT TRAYS
• Common Device Name: 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; suite 340; minneapolis, MN 55442
• MDR Report Key: 15326959
• Report Number: 3012307300-2022-16956
• Device Sequence Number: 12106206
• Product Code: BSP
• UDI-Device Identifier: 20351688076585
• UDI-Public: 20351688076585
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: A3797-24
• Device Catalogue Number: A3797-24
• Device Lot Number: 3938709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• 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