MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET

Model Number	IPN046311
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We still observed leaks at the level of the plunger of the lor syringe.The leaks occured over the level of 6 ml.It happened with several syringes.
Event or Problem Description
We still observed leaks at the level of the plunger of the lor syringe.The leaks occured over the level of 6 ml.It happened with several syringes.
Additional 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 empty kits with two 10ml plastic lor syringes.The syringes were visually examined.Visual examination of the syringes revealed that the syringes appear typical with no observed defects or anomalies.The returned sample was 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 (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 & 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.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with either returned sample.The reported complaint of the lor syringe leaking could not be confirmed based on the sample 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.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• MDR Report Key: 12352978
• Report Number: 3006425876-2021-00817
• Device Sequence Number: 4056058
• Product Code: OGE
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20H2136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1