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

Catalog Number MTO-05400-UCS

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The tuohy needle bent at the tip which blocked the catheter from being able to pass to the epidural space.A new kit had to be used.There was no adverse patient outcome other than having to be stuck again by a needle.

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 bent during use.The customer returned one epidural needle and lidstock.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears typical.Microscopic examination of the needle bevel revealed the needle tip is bent.The needle bevel appearance is similar to a needle bevel that has been pressed against a hard surface with force (reference files (b)(4)).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 1.47mm (c05156), which is within specification of 1.46mm-1.48mm per graphic nz-05500-003; rev 7.The id measured 0.046in (1.17mm) (c05157), which is within specification of 1.17mm per graphic kz-05500-007; rev 8.Other remarks: additional testing of the needle tips was performed by the manufacturing site to determine tip strength.Testing was performed to compare needle tips strengths from five available sets of different needles.The test concluded that the needle sets had very similar results.Specifications per graphic nz-05500-003; rev 7 and kz-05500-007 rev.8 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 review of the quality inspection report from the vendor of the cannula (nz-05500-001) found no material issues for lot # 72p16g0052 (vendor lot # mm160615aj) (reference files (b)(4)).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 tip bending during use was confirmed based on the sample received.Visual examination of the returned needle revealed the tip of the needle bevel was bent, which is consistent with damage that can be caused when a needle bevel is pressed against a hard surface.A device history record review was performed on the epidural needle with no relevant findings.No material issues were found from the vendor for the cannula.Also, a needle tip strength study was performed by the manufacturing site which revealed very similar results with five different sets of needles indicating that the needle in question does not show any material deficiencies or changes.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 tuohy needle bent at the tip which blocked the catheter from being able to pass to the epidural space.A new kit had to be used.There was no adverse patient outcome other than having to be stuck again by a needle.

• 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: 6619654
• MDR Text Key: 76953195
• Report Number: 1036844-2017-00239
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: MTO-05400-UCS
• Device Lot Number: 23F17C0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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