MAUDE Adverse Event Report: NULL NEEDLE, SPINAL, SHORT TERM; PORTEX EPIDURAL CONTINUOUS TRAYS

Lot Number 3793358

Device Problem Mechanical Jam (2983)

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

Event Date 11/30/2019

Event Type  malfunction  

Event Description

It was reported that while looking for the epidural space after pricking a patient, the syringe seemed to 'jam' after short interruptions during the prick at a contraction of a patient in labor.There was no loss, no liquid backflow due to the pressure at the jam.The resistance was found only after 'short breaks'.The set was changed.No patient injury reported.

Manufacturer Narrative

No product information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Customer complaints where similar failures were described have been recently received.Supplier investigation didn't identify the root cause of this issue.Under visual inspection no damage nor deformation on the samples were noted.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: NEEDLE, SPINAL, SHORT TERM
• Type of Device: PORTEX EPIDURAL CONTINUOUS TRAYS
• Manufacturer (Section G): NULL
• MDR Report Key: 15406482
• MDR Text Key: 305881961
• Report Number: 3012307300-2022-18787
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3793358
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1