MAUDE Adverse Event Report: TELEFLEX MEDICAL 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 06/22/2017

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

Tuohy needles are bending when entering the epidural space; unable to pass the catheter.There was no patient injury.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle with no relevant findings.A corrective action is not required at this time as the potential cause of the needle bending could not be determined based upon the information provided and without a sample.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 could not be determined based upon the information provided and without a sample.

Event Description

Tuohy needles are bending when entering the epidural space; unable to pass the catheter.There was no patient injury.

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 bent during use.The customer returned one epidural needle (b)(4).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.Microscopic examination of the needle tip revealed tip is bent.The needle bevel appearance is similar to a needle bevel that has been pressed against a hard surface with force.The stylet hub is also damaged (b)(4).The outer dimension (od) was measured.The od of the returned needle measured 1.47mm (c05155), which is within specification of 1.46mm-1.48mm per graphic nz-05500-003; rev 7.The inner dimension (id) of the returned needle could not be performed based on the damage to the stylet hub.Additional testing of the needle tips was performed by the manufacturing site to determine tip strength.Testing was performed to compare needle tips.Other remarks: 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 was 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 #'s 72p16h0089 and 72p16g0052 (vendor lot #'s mm160715aj and mm160615aj).Based on the increased number of bent needle complaints, capa request was initiated to further investigate this complaint issue.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 was bent.Also, 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 as well as the stylet hub being damaged.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.However, based on the increased number of bent needle complaints, capa request was initiated to further investigate this complaint issue.

Event Description

Tuohy needles are bending when entering the epidural space; unable to pass the catheter.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• 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: 6689796
• MDR Text Key: 79181416
• Report Number: 1036844-2017-00271
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• 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,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F17C0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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