MAUDE Adverse Event Report: HALYARD ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU; ANESTHESIA CONDUCTION KIT

Model Number TBT01089T

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Please reference: 2026095-2015-00117/(b)(6).Procedure: shoulder scope.Cathplace: interscalene nerve block.It was reported that an anesthesiologist performed two separate procedure on two pts and during each separate procedure experienced a catheter shearing.It was reported that the stylet wasn't "pulling out" after the catheter had been inserted.As the anesthesiologist was trying to pull the stylet back, the catheter started to shear.The catheters were removed on both pts and replaced with a catheter from another catheter kit in which "the stylet pulled out fine." the catheter for the second reported incident is available for return and analysis.Add'l info was received on (b)(6) 2015.It was reported that the shear of both catheters occurred during the removal of the stylets.The doctor experienced even more resistance when the doctor attempted to pull out the stylet for the second reported incident.The catheter sheared in the same manner as the first reported incident.No pt injury occurred.The lot number info was not available.Add'l info was received on (b)(6) 2015.It was reported that no add'l info was available.

Manufacturer Narrative

Method :the device was reported to be returning for an eval and at this time is pending return.The reporter was unable to provide a lot number; thus, the review of the device history record (dhr) cannot be conducted at this time.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a f/u report will be submitted.Please note: the spirol catheter belongs to a peripheral nerve block tray that is assembled by halyard, and the suspect catheter mentioned in this incident is a component of the tray and an epimed product.For this catheter, the product code is bso and the 510k number is k133316.

Manufacturer Narrative

It was clarified that the customer used catheters from the product code tbt01089t and not the previously reported tbt02100t.Methods: actual device was received for an eval and investigation.A flow test.Visual and microscopic inspection were conducted.A review of the device history record (dhr) and a process review was conducted for the reported model and lot number.Results: the visual inspection found the catheter had visible bends and kinks.While removing the stylet from the catheter, slight resistance was felt.However, the resistance experienced was only during the initial retraction of the stylet.The stylet was removed successfully, although a significant bend was observed at the stylet's distal end.Epimed believes that the bend in the stylet may have occurred as a result of the physician's technique, which may have attributed to the reported incident.Next, the entire catheter was examined under magnification.Once the catheter was completely examined, there was no evidence of any skiving and/or shearing to be found.However, while reviewing the catheter, stretching could be seen in both the distal and proximal windows of the catheter.Lastly, a flow test was conducted on the catheter and the catheter performed appropriately.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.The process review, which includes visual and functional inspections, indicates that the lot was manufactured according to approved procedures.Conclusions: per epimed's investigation, the catheter functioned appropriately.There was no evidence of a skive and/or shear on the returned catheter.When the catheter was removed, resistance was met during the initial retraction of the stylet and a bend was observed in the stylet, which could possibly be attributed to the physician's technique.Although, an assignable cause could not be determined.Per the reported information, the anesthesiologist met some resistance when pulling back the stylet.See scanned page.

• Brand Name: ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4672430
• MDR Text Key: 5607049
• Report Number: 2026095-2015-00118
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TBT01089T
• Device Catalogue Number: 104078400
• Device Lot Number: 0202070792
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR