MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN046629

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/06/2021

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

When placing an epidural for labor analgesia, i noted a small "fleck" of material in the glass loss or resistance syringe.I had already prepped and draped the back using normal sterile technique, injected local anesthesia using the local anesthesia syringe and placed the tuohy epidural needle.I then picked up the glass loss of resistance syringe which had been filled with 3 cc of ns from the glass vial in the kit using a filter needle.When i connected the syringe i noticed the "fleck" of dark material in the glass syringe which is not normally present.Because of this foreign substance, i aborted the procedure with this kit.I informed the rn and the patient as to the issue and got a new kit, new sterile gloves and reprepped and draped the back using the new kit.Using the new kit and standard sterile prep and technique i placed the epidural uneventfully.

Event Description

When placing an epidural for labor analgesia, i noted a small "fleck" of material in the glass loss or resistance syringe.I had already prepped and draped the back using normal sterile technique, injected local anesthesia using the local anesthesia syringe and placed the tuohy epidural needle.I then picked up the glass loss of resistance syringe which had been filled with 3 cc of ns from the glass vial in the kit using a filter needle.When i connected the syringe i noticed the "fleck" of dark material in the glass syringe which is not normally present.Because of this foreign substance, i aborted the procedure with this kit.I informed the rn and the patient as to the issue and got a new kit, new sterile gloves and reprepped and draped the back using the new kit.Using the new kit and standard sterile prep and technique i placed the epidural uneventfully.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the kit and the lor syringe with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the kit and lor syringe with no evidence to suggest a manufacturing related cause.The potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12325521
• MDR Text Key: 266700920
• Report Number: 1036844-2021-00156
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: 50801902013694
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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: 02/28/2022
• Device Model Number: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F21B0111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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