MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19GA X 35.; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05001-SLR

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The lor syringe becomes sticky once the liquid is drawn.Additional information states that the liquid was spinal fluid.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the glass lor syringe became sticky once fluid was drawn.The customer returned one 5ml lor syringe.The returned syringe was visually examined with and without magnification.Visual examination of the returned syringe revealed the syringe was typical with no anomalies or defects observed.It should be noted the syringe was received with the plunger fully inserted inside the barrel of the syringe.Functional testing was performed by attempting to slide the plunger inside the barrel of the syringe.The plunger would not slide.Additional testing of the sample was performed.The lor syringe was provided to the supplier ((b)(4)).The supplier tested the returned syringe and could not replicate the defect condition (reference files (b)(4)).A corrective action is not required at this time as other remarks: 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 glass syringe becoming sticky during use was confirmed based on the sample received.Function inspection revealed the plunger was stuck fully inside the barrel and would not slide at all.The sample was provided to the supplier and the defect condition could not be replicated.It is unknown how the product was handled prior or during use or at what point the syringe was exposed to any liquids.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.

Event Description

The lor syringe becomes sticky once the liquid is drawn.Additional information states that the liquid was spinal fluid.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19GA X 35.
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6439330
• MDR Text Key: 71048047
• Report Number: 1036844-2017-00125
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: ASK-05001-SLR
• Device Lot Number: 23F16H0998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2016
• 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