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

Catalog Number MP-17019-TKL

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While performing a labor epidural placement, the tuohy needle tip folded over.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle tip folded during use.The customer returned one sealed kit for evaluation.No actual complaint sample was received.The epidural needle from the sealed kit was visually examined with and without magnification.Visual examination of the returned needle revealed that the needle appeared typical with no observed defects or anomalies.The needle bevel appears typical.No burrs or deformations were observed.The needle stylet fills the bevel appropriately.The needle cannula is smooth.An attempt was made to bend the needle by pressing the needle tip against a hard metal surface.The needle bevel did bend slightly but the tip did not fold.However, great pressure was applied.The same test was performed on a lab inventory epidural needle of the same kind with similar results.A corrective action is not required at this time as the potential root cause could not be determined based upon the information provided and without the other remarks: actual complaint sample.Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.The customer returned a sealed kit only.The epidural needle from the sealed kit appeared typical with no observed defects.An attempt was made to bend the returned needle by pressing the needle bevel against a hard surface.However, the returned needles resulted in similar results to a lab inventory needle of the same kind.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle tip folding during use could not be determined based upon the information provided and without the actual complaint sample.

Event Description

While performing a labor epidural placement the tuohy needle tip folded over.The patient's condition was reported as unknown.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• 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: 5915542
• MDR Text Key: 53553945
• Report Number: 1036844-2016-00449
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: 23F16E0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2016
• 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