MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK TRAY; REGIONAL ANESTHESIA

Model Number TBT03100T

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 26-mar-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).No device returned.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.A physician reported that a catheter sheared away inside of a patient during a nerve block procedure.Additional information received 08-mar-2018 stated a small portion of the device was left in the patient.This occurred while performing a continuous nerve bloc procedure.No additional information was provided.

Manufacturer Narrative

All information reasonably known as of 13-apr-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

Additional information received 27-mar-2018 stated the surgeon decided to leave the broken catheter piece in place with no concerns.There was only about half a centimeter retained in the patient.The anesthesiologist advanced the catheter with stylet past the tuohy tip needle and once he pulled it back the needle sheared the catheter.

Manufacturer Narrative

The catheter was examined.The catheter¿s distal tip coating and internal spring were sheared off from the device.Measurement testing was conducted and it was determined that approximately 1/8¿ of the catheter¿s distal end coating was sheared off from the device.The catheter¿s internal spring was stretched but remained intact.The returned catheter was examined using the ram optical measurement system.During this examination, it was discovered that the direction of the coating shear was from the proximal end of the catheter tracking towards the catheter¿s distal end.A cut was observed approximately 1¿ from the catheter¿s distal end.Because the damage to the catheter began approximately 1¿ from the catheter¿s distal end and tracked towards the catheter¿s distal tip, it was suspected that the damage most likely derived from the catheter being withdrawn while the needle was still in place.Per instructions for use, (spirol epidural catheter products) ¿caution: if excessive resistance is encountered, stop, remove both needle and catheter as a unit and attempt new puncture.To avoid shearing catheter, never withdraw catheter back against needle bevel.¿ the complaint stated that the physician advanced the catheter with the stylet past the tuohy needle tip and when he pulled the catheter back the needle sheared the catheter.This confirms that the damage to the catheter was derived from the physician withdrawing the catheter while the needle was still in place.The tuohy needle that was used in the reported complaint but was not returned for investigation.It has been determined that the catheter was withdrawn while the needle was still in place, subsequently causing the damage to the catheter.The root cause was inappropriate use.All information reasonably known as of 06-jun-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Type of Device: REGIONAL ANESTHESIA
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7385859
• MDR Text Key: 104155863
• Report Number: 3006646024-2018-00007
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30680651407871
• UDI-Public: 30680651407871
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TBT03100T
• Device Catalogue Number: 104078703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1