MAUDE Adverse Event Report: NULL PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Lot Number 3941057

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

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.Visual inspection found he returned sample did not reveal any visible defects or anomalies.Functional testing found returned syringe sample passed the loss of resistance (l.O.R.) test and leakage test without issue.When testing the fit between the stop ring (inside diameter) of the syringe barrel and the stop ring on the plunger (outside diameter), it was noted that the sample failed to have a frictional fit.The plunger of the returned sample, was easily removed from the syringe barrel, indicating that the fit was not acceptable between the stop rings.Further investigation of the components dimensionally, revealed that the stop ring diameter of the syringe barrel was over specification.This allowed the plunger to be removed from the barrel too easily.All other components were found to be within specification.The root cause of the reported issue was found to be supplier out of specification nonconformance.The syringe barrel has been removed from the certified product list and a heightened inspection is in place for future receipts.Therefore, 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.No information has been provided to date) this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

Event Description

It was reported that when handling the syringe for loss of resistance, during the epidural, the plunger of the syringe slides badly inside the syringe which gives a blow and in fact, create a movement causing a hole in the [hardness].The rings that are on the piston, the first is slightly too wide! this creates a point of friction.No patient injury reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15324619
• MDR Text Key: 305530782
• Report Number: 3012307300-2022-16879
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2023
• Device Lot Number: 3941057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1