MAUDE Adverse Event Report: HALYARD - IRVINE PERIFPHERAL NERVE BLOCK SUPPORT TRAY; ANESTHESIA CONDUCTION KIT

Model Number TBT03100T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

Procedure: tap block.Cathplace: tap block.It was reported that an incident of a catheter break occurred.It was reported that a catheter shred during placement.The device is available for return.Additional information was received on 04/27/2015: the block was performed under ultrasound guidance and ropivacaine was used to bolus the area.The catheter was advanced 1-2cm inside of the patient.Resistance was met when inserting the catheter and the needle was still in place when the catheter was removed.When the anesthesiologist pulled back on the catheter, the catheter shred.A small black piece, which was believed to be the catheter tip along with the needle and rest of the catheter and inner coil were removed from the patient and the procedure was completed with a different brand of needle and catheter with no further issues.No patient injury occurred.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) for the reported lot number is currently in process.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 follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Method - actual device not evaluated.Methods: it was previously reported that the device was available for return; however, it was subsequently reported that the device was lost or discarded and is now unavailable for evaluation.Results: as the device was not available for an evaluation, no device testing methods were performed and results cannot be obtained.However, the device history record (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: the device was not returned to halyard for evaluation; therefore, we are unable to determine the cause for the reported event.It was reported that the catheter was advanced 1-2cm inside of the patient.Resistance was met when inserting the catheter and the needle was still in place when the catheter was removed.The instructions for use (ifu) (pi-009) specifies warnings: "do not remove catheter while needle is in place.Spirol catheter and epidural needle must be removed together as a unit to prevent potential catheter damage." based on the reported information, a failure to follow instructions may have contributed to the reported incident; however, a root cause cannot be determined.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.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: PERIFPHERAL NERVE BLOCK SUPPORT TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4774771
• MDR Text Key: 5777932
• Report Number: 2026095-2015-00151
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Model Number: TBT03100T
• Device Catalogue Number: 104078700
• Device Lot Number: 0201386594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2014
• 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: 36 YR