MAUDE Adverse Event Report: ST PAUL PORTEX; PAIN MANAGEMENT

Catalog Number 100/496/127

Device Problems Separation Failure (2547); Positioning Problem (3009)

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

Event Date 06/15/2021

Event Type  Injury  

Event Description

Information received a smiths medical pain management|portex spinal needles caused foreign body removal.The report indicated approximately 1 and 1 and 4th inches of the spinal needle broke off while the consultant removed the needle with the introducer simultaneously and needle fragment remained inside the patient.Xray preformed in theatre afterwards to see if portion of needle could be removed, successful removal of needle fragment without any additional complications.

Manufacturer Narrative

Other, other text: the device is a supplied item.It was returned broken and forwarded to the supplier for further investigation.

Event Description

Approximately 1 and 1 and 4 th inches of the spinal needle broke off while the consultant removed the needle with the introducer simultaneously and needle fragment remained inside the patient.Xray preformed in theatre afterwards to see if portion of needle could be removed, successful removal of needle fragment without any additional complications.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).(required medical intervention - removal of metal by surgery/xrays).

• Brand Name: PORTEX
• Type of Device: PAIN MANAGEMENT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12177616
• MDR Text Key: 261827448
• Report Number: 3012307300-2021-07271
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/496/127
• Device Lot Number: 4072396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male