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 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that with syringes included in kits jc-05400-b (after the recall), we faced 3 incidents of the plunger of the lor syringe leaking.The anaesthesists were not able to locate the epidural space and made dural tears for each of the 3 female patients involved.For the incident of the 31st of august, a blood patch was applied.Not for the other two.Patients are fine.

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 leaked.The customer returned one sealed representative kit from the same lot # as reported on the complaint ((b)(4)) for investigation.The actual complaint sample was not returned.The returned kit was opened and the 10ml plastic lor syringe was removed and was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The received sample was returned to the supplier (preox) for function testing.According to the supplier, no leak was found with the returned syringe.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released (b)(6) 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 & polymrs (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 syringe was 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 sample received was visually inspected with no issues.The syringe was returned to the supplier (preox) where the syringe was 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 a representative sample was received.The returned lor syringe was 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.Therefore, a potential root cause could not be determined based upon the information provided or without the actual complaint sample.

Event Description

It was reported that with syringes included in kits jc-05400-b (after the recall), we faced 3 incidents of the plunger of the lor syringe leaking.The anaesthesists were not able to locate the epidural space and made dural tears for each of the 3 female patients involved.For the incident of the (b)(6), a blood patch was applied.Not for the other two.Patients are fine.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10599529
• MDR Text Key: 208942969
• Report Number: 3006425876-2020-00827
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20E0691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2020
• 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
• Patient Outcome(s): Other; Required Intervention