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

Model Number IPN038182

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

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

The report states: we have been facing a few issues with the plunger of the syringes.It is leaking so it is impossible to use it on the patients.It happened with 2 lot numbers, 71f19g0974 and 71f19k2112.No consequence reported but the customer wants a solution found to make sure the mothers can give birth with no pain.

Event Description

The report states: we have been facing a few issues with the plunger of the syringes.It is leaking so it is impossible to use it on the patients.It happened with 2 lot numbers, 71f19g0974 and 71f19k2112.No consequence reported but the customer wants a solution found to make sure the mothers can give birth with no pain.

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 (71f19g0974) for investigation (reference files (b)(4)).The actual complaint sample was not received.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.Functional testing was performed on the returned syringe using the lab leak tester (c05176) per the parameters in amrq-000155 rev.6, section 7.2-positive pressure leakage.Water was aspirated into the syringe to the 8ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.A leak was detected.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released 03-dec-2018), supplier (preox) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531, b.Changed to new plunger tool, c.Changed to new mold for blue stopper.D.Changed molding location for the plunger and the blue stopper as follows.Plunger: from fleimaplastic in germany to gpe, germany.Blue stopper: from et, germany to psilkon, germany.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The reported complaint of the lor syringe leaking was confirmed based on the sample received.The returned lor syringe did not pass functional leak testing.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.However, based on the observed leak, the potential root cause of this issue is supplier related.A scar has been initiated to further investigate this issue.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9511699
• MDR Text Key: 179444064
• Report Number: 3006425876-2019-01095
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 12/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: IPN038182
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F19G0974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1