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

Catalog Number JC-05400-B

Device Problems Fluid/Blood Leak (1250); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the anesthetist informed on issue with the syringes.There is a leak and even separation of the blue seal from plunger.There were no consequences to the patient.

Event Description

It was reported that the anesthetist informed on issue with the syringes.There is a leak and even separation of the blue seal from plunger.There were no consequences to the patient.

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 one 10ml plastic lor syringe (reference 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 function testing.According to the supplier, "no leakage found by normal handling, leakage if plunger moved to the side".A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per (b)(4) (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 (b)(4) in germany to (b)(4), germany.Blue stopper: from (b)(4), germany to (b)(4), germany.These effective changes did impact product design and material.It should be noted; the returned lor syringe was from the new design.A scar was initiated to further investigate this complaint issue.The reported complaint of the lor syringe leaking was confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where according to the supplier, "no leakage found by normal handling, leakage if plunger moved to the side".A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.However, based on the functional testing by the supplier, 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 KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9305043
• MDR Text Key: 179121041
• Report Number: 3006425876-2019-00843
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19G2837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.