MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN046311
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The plunger of the lor syringe slides out of the syringe barrel without any force being applied.This issue was already noted on approximately 20 devices in a period from october to december.
Additional 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 plunger slides out of the barrel without any force applied.The customer returned one 10ml plastic lor syringe and lidstock (reference attached files (b)(4)).The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for further evaluation.According to the supplier, the returned lor syringe had a low or no "plunger stop".The supplier indicated a plunger stop is part of the barrel and is a bead on the inner surface of the barrel.It helps prevent the plunger from being pulled over the end of the barrel without some force required.The supplier said that a low or missing plunger stop is not required for the syringe and is not considered a defect as there is no specification.Also, does not impact the functionality of the syringe.The supplier performed functional testing on the returned syringe.The supplier indicated the plunger would not slide out of the barrel without some force applied.Also, leak testing was performed with no leak found.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.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 plunger slides out of the barrel without any force applied could not be confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for evaluation.According to the supplier, the returned syringe had a low or no "plunger stop".The supplier indicated a low or no plunger stop is not required for the syringe and is not considered a defect as there is no specification.Also, it does not affect the functionality of the syringe.The supplier performed functional testing on the returned syringe and indicated the plunger would not slide out of the barrel without some force applied.Also, leak testing was performed with no leak 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, the returned syringe functioned as intended as no functional issues were found.No further action is required at this time.
Event or Problem Description
The plunger of the lor syringe slides out of the syringe barrel without any force being applied.This issue was already noted on approximately 20 devices in a period from october to december.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13112893
• Report Number: 3006425876-2021-01221
• Device Sequence Number: 16967954
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140110
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 08/31/2023
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F21J1424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown