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

Catalog Number MP-17019-TK

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

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

The epidural needle bent upon insertion.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The customer reported the epidural needle bent during use.The customer returned one epidural needle with stylet and guard.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears used.The cannula of the returned needle is bent compared to a lab inventory needle.Microscopic examination of the needle bevel revealed biological material can be seen at the tip and the needle tip is slightly bent.The needle bevel appearance is similar to a needle bevel that has been pressed against a hard surface with force.A dimensional inspection was performed on the returned epidural needle.The outer dimension (od) and inner dimension (id) of the returned needle was measured.The od of the returned needle measured 1.48mm (c05155), which is within specification of 1.46mm-1.48mm per graphic nz-05500-003; rev 6.The id measured 0.046in (1.17mm) (c05157), which is within specification of 1.17mm per graphic kz-05500-007; rev 7.An attempt was made recreate the observed damage using a lab inventory needle.The needle tip was inserted into a stable material and the needle hub other remarks: was torqued at an angle in order to recreate the event.The observed results of the lab inventory were similar to what was observed in the returned needle.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no relevant findings.Specifications per graphic nz-05500-003; rev 6 and kz-05500-007 rev.7 were reviewed as a part of this complaint investigation.A review of design change history for part number nz-05500-001 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.The damage was discovered during use.Therefore, based on the condition of the sample received and the time of discovery, operational context caused or contributed to this event.The reported complaint of the needle being bent during use was confirmed based on the sample received.Visual examination of the returned needle revealed the cannula and tip of the needle bevel were slightly bent, which is consistent with damage that can be caused when a needle bevel is pressed against a hard surface and torqued.An attempt to recreate the event was performed using a lab inventory needle of the same kind.The bend in the lab inventory needle had similar results as the returned needle.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural needle with no relevant findings.Therefore, based upon the information provided, the observed needle damage, and the time of discovery, operational context caused or contributed to this event.

Event Description

The epidural needle bent upon insertion.The patient's condition was reported as fine.

• 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: 6169596
• MDR Text Key: 62247380
• Report Number: 1036844-2016-00667
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP-17019-TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• 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