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

Catalog Number OU-05500-J

Device Problem Physical Resistance (2578)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the flushing test before use, the plunger did not glide inside the lor syringe smoothly due to resistance.

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 returned for analysis.A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the syringe plunger not sliding smoothly could not be determined based upon the information provided and without the sample.

Event Description

During the flushing test before use, the plunger did not glide inside the lor syringe smoothly due to resistance.

Manufacturer Narrative

(b)(4).The customer returned one glass 5ml lor syringe and lidstock.Prior to decontamination, the returned syringe was visually examined with and without magnification.Visual examination of the returned syringes revealed a dried substance on the plunger of the syringe.No residue was seen on the barrel or tip.After decontamination of the syringe, the substance was gone from the barrel and the syringe appeared typical.No other defects or anomalies were observed.Prior to decontamination, an attempt was made to slide the syringe plunger inside the barrel.The tip of the plunger could only be inserted to just below the 2ml mark on the barrel.At the same time, the dried substance on the plunger could be seen at the top of the barrel which was preventing the plunger from being fully inserted.After decontamination of the returned syringe, an attempt once again to slide the syringe plunger inside the barrel was performed.Other remarks: the syringe plunger will slide in and out of the barrel with little resistance met.The movement in the syringe barrel feels typical.The returned syringe was functionally tested per pip-191 plunger movement test.The neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.The plunger was then released.The plunger fell freely to the bottom of the syringe barrel.The test was repeated twice, rotating the plunger 90 and 180 degrees.The plunger was able to freely fall each time.There were no functional issues found.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 the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the plunger would not glide smoothly was confirmed based on the sample received.It is unknown how the product was handled prior or during use or at what point the syringe was exposed to any substances.A device history record review was performed on lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the syringe not functioning properly could not be determined.Teleflex will continue to monitor and trend related events.

Event Description

During the flushing test before use, the plunger did not glide inside the lor syringe smoothly due to resistance.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 6649678
• MDR Text Key: 77841021
• Report Number: 3006425876-2017-00206
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: OU-05500-J
• Device Lot Number: 71F16F1642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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