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 06/17/2020

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: there was a leak of the lor syringe (air in the syringe).There was no consequence for the patient but there could be a mistake made in the epidural space by the anesthetist.We put this lot# in quarantine.The incident happened prior to insertion in the patient.It happened during the test of the device.The plunger was loose.The anesthetist used another syringe from another supplier.The actual device was discarded but representative samples are available.

Event Description

It was reported that: there was a leak of the lor syringe (air in the syringe.There was no consequence for the patient but there could be a mistake made in the epidural space by the anesthetist.We put this lot# in quarantine.The incident happened prior to insertion in the patient.It happened during the test of the device.The plunger was loose.The anesthetist used another syringe from another supplier.The actual device was discarded but representative samples are available.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned two sealed representative kits from the same lot # as reported on the complaint (71f20d0529) for investigation.The actual complaint sample was not received.The returned kits were opened and the 10ml plastic lor syringe was removed and was visually examined.Visual examination of both syringes revealed that the syringes appear typical with no observed defects or anomalies.The returned sample were returned to the supplier (preox) for function testing.According to the supplier, no leak was found with either returned syringe.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.It should be noted, the returned lor syringes were from the new design.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative samples received were visually inspected with no issues.The syringes were returned to the supplier (preox) where both syringes were functionally tested with no issue found.The reported complaint of the lor syringe leaking could not be confirmed based on the sample received.The actual complaint sample was not returned; only two representative samples were received.The returned lor syringes were returned to the supplier (preox) for functional testing where no issues were found.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on the supplier's results, no issues were found with the returned sample.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10178359
• MDR Text Key: 196060483
• Report Number: 3006425876-2020-00567
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20D0529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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