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

Catalog Number ASK-05500-KM

Device Problem Air Leak (1008)

Patient Problem Not Applicable (3189)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

While flush testing the lor syringe before use, the user noticed air-leakage from the gap between the plunger and barrel.A new kit was used instead.

Manufacturer Narrative

(b)(4).The customer reported the lor syringe was leaking between the barrel and plunger.The customer returned one glass lor syringe and lidstock (reference attached files (b)(4)).Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.After functional testing, microscopic examination was performed on the returned plunger since the leak was detected when the plunger was inserted into the barrel of the returned syringe as well as a lab inventory syringe.No visual defects or anomalies were observed with the returned plunger as compared to a lab inventory plunger (reference files (b)(4)).Functional testing was performed on the returned syringe using the lab leak tester ((b)(4)) per the parameters in amrq-000128 rev.3, section 7.2-positive pressure leakage.Water was aspirated into the syringe 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 could be seen between the barrel and plunger of the syringe.The test was performed once again using a lab inventory barrel and the returned plunger.Again a leak was other remarks: detected between the barrel and plunger.The test was performed once again with the returned barrel and a lab inventory plunger.No leaks were detected.Indicating there is an issue with the syringe plunger.Microscopic examination was performed on the returned plunger.No visual defects or anomalies were observed with the returned plunger as compared to a lab inventory plunger.Nonconformance, (b)(4), have been initiated to further investigate this complaint issue.The reported complaint of the lor syringe leaking was confirmed based on the sample received.Functional testing revealed the lor syringe was found to be leaking around the barrel and plunger.Visual examination of the returned sample did not reveal any defects of anomalies as compared to a lab inventory syringe.A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue.The lor syringe is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance, (b)(4), has been initiated to further investigate this issue.

Event Description

While flush testing the lor syringe before use, the user noticed air-leakage from the gap between the plunger and barrel.A new kit was used instead.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe leaking could not be determined based upon the information provided and without the sample.

Event Description

While flush testing the lor syringe before use, the user noticed air-leakage from the gap between the plunger and barrel.A new kit was used instead.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 6404360
• MDR Text Key: 69946451
• Report Number: 3006425876-2017-00084
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: ASK-05500-KM
• Device Lot Number: 71F16G0393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1