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

Catalog Number AK-05502

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

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

The epidural needle bent during use.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4) a device history record review was performed on the epidural needle with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did however, provide a photo that shows a bent epidural needle ((b)(4)).A corrective action is not required at this time.Although, the customer provided a photo that illustrates a bent needle, a potential root cause could not be determined based on the information provided and without a sample.The reported complaint of a bent needle was confirmed based on a photo provided by the customer.However, complaint verification testing could not be performed as no sample was returned for analysis.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 bending during use could not be determined based upon the information provided and without a sample.

Event Description

The epidural needle bent during use.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• 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: 5915456
• MDR Text Key: 53553750
• Report Number: 1036844-2016-00457
• 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: 08/04/2016

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: 06/30/2017
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F16A0185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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