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

Model Number IPN046311

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

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

It was reported that the plunger is air leaking.The doctor(anesthetist) faced 2 incidents during the night of (b)(6) 2020.With 2 different lot numbers.Lot#:71f20e0804 and 71f20e0956.There was no consequence for the two female patients but a risk.During the week 35 (17 to 23 aug 20),another doctor(anesthetist) faced 2 incidents with lot# 71f20e0804 and 71f20e095.The consequences for the 2 female patients were: dura mater breaches so a blood patch had to be applied for each.

Event Description

It was reported that the plunger is air leaking.The doctor(anesthetist)faced 2 incidents during the night of wednesday (b)(6) 2020.With 2 different lot numbers.Lot#:71f20e0804 and 71f20e0956.There was no consequence for the two female patients but a risk.During the week 35 (17 to 23 aug 20),another doctor(anesthetist) faced 2 incidents with lot# 71f20e0804 and 71f20e095.The consequences for the 2 female patients were: dura mater breaches so a blood patch had to be applied for each.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released 12-mar-2020), supplier (preox) made the following changes: optional component materials/mold locations: option 1: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene 100-ga12 ineos olefins & polymers (molded at fleima plastic) blue stopper: silicone rubber (molded at et elastomer technik).Option 2: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene profax pf-531 lyondell-basell (molded at gpe) blue stopper: silicone rubber (molded at psilkon).Lubricant: - the i.D.Of the barrel lubricated w/ medical grade silicone (polydimethylsiloxan) and amount will not exceed 0.25mg per sq centimeter.These effective changes did impact product design and material.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 without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10536599
• MDR Text Key: 207340984
• Report Number: 3006425876-2020-00787
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20E0956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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