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

Catalog Number AK-05502

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(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 the anesthesiologist was utilizing the glass loss of resistance syringe technique while placing an epidural.The syringe was noted to jam which resulted in a dural puncture.This patient may need a blood patch as a result.On follow up, it was reported that the patient did not require a blood patch.

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 was not sliding.The customer returned one glass 5ml lor syringe and lidstock.The returned lor syringe was visually examined with and without magnification.Visual examination of the returned syringe appears typical with no defects or anomalies observed.Prior to decontamination, an attempt was made to slide the syringe plunger inside the barrel.The returned syringe plunger would slide but with some resistance.After decontamination of the returned syringe, an attempt once again to slide the syringe plunger inside the barrel was performed.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pip-191; rev 05 plunger movement test.A neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.The plunger was then released.The plunger fell freely to the bottom of the syringe barrel.The test was repeated twice,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.The reported complaint of the lor syringe not sliding could not be confirmed based on the sample received.The returned syringe performed typically , and the syringe passed the plunger movement test per pip-191.There were no functional issues found with the returned syringe.

Event Description

It was reported that the anesthesiologist was utilizing the glass loss of resistance syringe technique while placing an epidural.The syringe was noted to jam which resulted in a dural puncture.This patient may need a blood patch as a result.On follow up, it was reported that the patient did not require a blood patch.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• 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: 8695990
• MDR Text Key: 147901793
• Report Number: 1036844-2019-00725
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19C0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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