MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX LANCET POINT SPINAL NEEDLES WITH NRFIT CO; NEEDLE, SPINAL, SHORT TERM

Catalog Number 15739-21

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/26/2021

Event Type  malfunction  

Event Description

It was reported that while using the spinal kitsin the operating room (or), the spinal introducer needle got separated from the hub while in a patient.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A used and decontaminated introducer needle sample was received for evaluation, along with a photo.Visual inspection found detachment was evident and using visual magnification revealed differences from the complaints sample and those from stock.Functional test of the available stock was performed and all of the stock samples exceeded minimum specifications for hub/cannula security.It also appeared that the returned sample had been crimped multiple times versus the stock samples.The allegation was confirmed; however, the root cause of the issue could not be determined.The appropriate supplier engineer has been notified regarding this defect and the supplier was contacted.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.D4 unique identifier and g5 are unknown.No 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 LANCET POINT SPINAL NEEDLES WITH NRFIT CO
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• 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; minneapolis, MN 55442
• MDR Report Key: 15299982
• MDR Text Key: 303559309
• Report Number: 3012307300-2022-16331
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 15739-21
• Device Lot Number: 4038165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 08/26/2022
• 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