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

Model Number IPN045612

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

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

It was reported that there was loss of liquids between the piston and the inner walls of the syringe.

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 (reference files inp(b)(4)).The actual complaint sample was not received.The ret urned 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.4, 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.No leaks were detected.The plunger was rotated 45deg and the syringe was once again tested at 10psi for 10 seconds and no leaks were detected.This was performed by rotating the plunger 45deg until the plunger had rotated a full 360deg with no leaks 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 with the plunger being rotated 45deg until it had rotated a 360deg with no leaks being d etected.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The luer end of the returned syringe was capped.With the tip sealed, the lor syringe was tested for leaks by pushing the plunger into the barrel.This was performed at 8ml, 5ml, and 2ml by pushing the plunger and rotating 45deg until the plunger had rotated a full 360deg.No leaks or slippage of the plunger occurred.An attempt to remove the plunger from the barrel was performed.The plunger seal snapped back when attempting to remove from the barrel.This was also performed with a lab inventory syringe with the same results.This indicates the plunger seal was creating a vacuum with no issues.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released (b)(6) 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 (b)(6), germany - blue stopper: from et, germany to (b)(6), germany 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 functionally tested and visually inspected with no issue found.

Event Description

It was reported that there was loss of liquids between the piston and the inner walls of the syringe.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9395272
• MDR Text Key: 179260933
• Report Number: 3006425876-2019-01017
• 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,u
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: IPN045612
• Device Catalogue Number: ALZANO-05400-B
• Device Lot Number: 71F19H1633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.