MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number OU-05500-NRON

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

The plunger of lor syringe did not slide during preparation for the procedure.Therefore, a new kit was opened instead.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe was not sliding.The customer returned one glass 5ml lor syringe nrfit and lidstock.The returned lor syringe was visually examined with and without magnification.Visual examination of the returned syringe appears typical with no defects or anomalies observed.Prior to decontamination, an attempt was made to slide the syringe plunger inside the barrel.The returned syringe plunger would not slide.After decontamination of the returned syringe, an attempt once again to slide the syringe plunger inside the barrel was performed.The syringe plunger will slide in and out of the barrel with little resistance met.The movement in the syringe barrel feels typical.The returned syringe was functionally tested per pip-191; rev 05 plunger movement test.A neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.The plunger was then released.The plunger fell freely to the bottom of the syringe barrel.The test was repeated twice, rotating the plunger 90 and 180 degrees.The plunger was able to freely fall each time.There were no functional issues found after the returned syringe was decontaminated.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the lor syringe not sliding was confirmed based on the sample received.Prior to decontamination, the plunger was stuck inside the barrel and would not slide at all.After decontamination, the returned lor syringe functioned as intended, including passing a plunger movement test.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.It is unknown how the lor syringe was handled prior to and during use.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.

Event Description

The plunger of lor syringe did not slide during preparation for the procedure.Therefore, a new kit was opened instead.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 11894465
• MDR Text Key: 256222353
• Report Number: 3006425876-2021-00518
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Catalogue Number: OU-05500-NRON
• Device Lot Number: 71F20H3119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.