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

Model Number IPN046311

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/29/2020

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

Anesthesiologist from maternity department contacted me last week regarding epidural kit jc-05400-b: the lor syringe leaks when used as per ifu.The anesthesiologist did a demonstration with brand new syringe: i could observe the leakage.I have the syringe from test available for investigation.Unfortunately, i do not know the lot number of this specific syringe.Nevertheless, the anesthesiologist advised me yesterday that the same issue was observed on several lots currently at the maternity.Those lots are 71f20h2136, 71f20j2236, 71f20e0691 and 71f20e0379.Additional information: the syringe was being used for lumbar puncture l3l4 in a sitting position.Loss of resistance with liquid mandrel using the loss of resistance syringe from the kit arrow filled with saline solution nacl 0.9% up to the 10ml graduation.Before the procedure no test was performed to verify if the syringe is properly working.If the packaging of the kit is intact it is deemed to be sterile and flawless.There is no false positive test.At 5cm deep clear loss of resistance testifying to the penetration into space epidural; at the same time leakage of saline solution between syringe which surprised the user.

Event Description

Anesthesiologist from maternity department contacted me last week regarding epidural kit jc-05400-b: the lor syringe leaks when used as per ifu.The anesthesiologist did a demonstration with brand new syringe: i could observe the leakage.I have the syringe from test available for investigation.Unfortunately, i do not know the lot number of this specific syringe.Nevertheless, the anesthesiologist advised me yesterday that the same issue was observed on several lots currently at the maternity.Those lots are 71f20h2136, 71f20j2236, 71f20e0691 and 71f20e0379.Additional information: the syringe was being used for lumbar puncture l3l4 in a sitting position.Loss of resistance with liquid mandrel using the loss of resistance syringe from the kit arrow filled with saline solution nacl 0.9% up to the 10ml graduation.Before the procedure no test was performed to verify if the syringe is properly working.If the packaging of the kit is intact it is deemed to be sterile and flawless.There is no false positive test.At 5cm deep clear loss of resistance testifying to the penetration into space epidural; at the same time leakage of saline solution between syringe which surprised the user.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Six sealed representative samples with the same kit # were also returned.Two with lot# 71f20h2136, two with lot# 71f20j2236, one with lot# 71f20e0379, and one with lot# 71f20e0691.The six kits were given to r & d for further evaluation.The returned 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 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 syringe was from the new design.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with the returned sample.The reported complaint of the lor syringe leaking could not be confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where no issues were found.A device history record review could not be performed as no lot number was provided by the customer.Based on the supplier's results, no issues were found with the returned sample.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe (reference attached files inp1900082008).The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Six sealed representative samples with the same kit # were also returned.Two with lot# 71f20h2136, two with lot# 71f20j2236, one with lot# 71f20e0379, and one with lot# 71f20e0691.The six kits were given to r & d for further evaluation.The returned sample was returned to the supplier (preox) for function testing.When the supplier's test results are available, this complaint will be reopened and the investigation will be updated.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 syringe was from the new design.A corrective action is not required at this time.The returned sample was returned to the supplier for function testing.When the supplier's test results are available, this complaint will be reopened and the investigation will be updated.The reported complaint of the lor syringe leaking could not be confirmed.The returned lor syringe was returned to the supplier (preox) for functional testing.When the supplier's test results are available, this complaint will be reopened and the investigation will be updated.A device history record review could not be performed as no lot number was provided by the customer.Based on this, the potential cause of this complaint could not be determined.

Event Description

Anesthesiologist from maternity department contacted me last week regarding epidural kit jc-05400-b: the lor syringe leaks when used as per ifu.The anesthesiologist did a demonstration with brand new syringe: i could observe the leakage.I have the syringe from test available for investigation.Unfortunately, i do not know the lot number of this specific syringe.Nevertheless, the anesthesiologist advised me yesterday that the same issue was observed on several lots currently at the maternity.Those lots are 71f20h2136, 71f20j2236, 71f20e0691 and 71f20e0379.Additional information: the syringe was being used for lumbar puncture l3l4 in a sitting position.Loss of resistance with liquid mandrel using the loss of resistance syringe from the kit arrow filled with saline solution nacl 0.9% up to the 10ml graduation.Before the procedure no test was performed to verify if the syringe is properly working.If the packaging of the kit is intact it is deemed to be sterile and flawless.There is no false positive test.At 5cm deep clear loss of resistance testifying to the penetration into space epidural; at the same time leakage of saline solution between syringe which surprised the user.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11244930
• MDR Text Key: 232759675
• Report Number: 3006425876-2021-00047
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• 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,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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