MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q QUIKBLOC OVER-THE-NEEDLE CATHETER SETS; REGIONAL ANESTHESIA

Model Number TB100ST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2017 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) device not returned.

Event Description

Fill volume: unknown, flow rate: unknown, procedure: shoulder surgery, cathplace: interscalene block.It was reported that a patient experienced difficulty removing a nerve block catheter.It was noted that the anesthesiologist basically sewed it in and out of the patient's skin, and then did a final insertion.The patient stated that when his wife attempted to remove it, it was not difficult to remove but when she starts to tug at it, the patient feels "an electrical shock and intense pain" as if it were rubbing against a nerve.The patient's wife tried twice, and it was the same scenario both occasions.The patient was advised to call the anesthesiologist to speak with them regarding the issue and the unique way it was inserted.The patient noted a lack of confidence with anesthesia, and opted for the paramedics to come and remove it.The patient went to the surgery center to have the catheter removed by anesthesia.It was suggested that reposition his arm.However, since the patient is post shoulder surgery, he is not allowed to move his arm.The anesthesiologist could not see the catheter under the ultra sound.An attempt to flush it was normal saline was made, but the patient could not tolerate due to the pain.The pain radiated down to his left arm but not his fingers.There was no paresthesia, only pain.The anesthesiologist sent the patient to the local hospital for interventional radiology evaluation.At this time, the patient underwent a ct scan and is now awaiting results.Overall, the patient was doing well.Additional information received on (b)(6) 2017 stated that the patient did go into surgery and had the catheter removed on saturday.The surgery was uneventful.The anesthesiologist noted that the catheter was not difficult to remove once they were able to get under the patient's skin.It was unknown what caused the catheter to be difficult to remove.There were no unusual maneuvers reported by the patient.The anesthesiologist did tunnel this catheter during placement.Additional information received on (b)(6) 2017 stated that the catheter was stuck on the brachial plexus.However, when the patient's skin layers were opened, the catheter fell out and was able to be removed with ease.The patient had no residual pain nor signs of nerve damage.There was no report about any malfunction of the catheter.It was no known reason why this catheter was stuck.No further information was provided.

Manufacturer Narrative

All information reasonably known as of 17-jul-2017 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 (b)(6) 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 (b)(6).(b)(6) 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 (b)(6) complaint database and identified as complaint (b)(4).

Event Description

Additional information received on 26-jun-2017 via medwatch mw5070258 which stated: "patient with on-q catheter (indwelling catheter for pain pump for post op pain management) on day 3 the patient's wife went to remove the catheter per protocol and she was only able to pull 3/4 of an inch.The catheter would not come out any further and the patient complained of severe pain when she tried.Facility anesthesiologist assesses the patient over the phone and had the patient come back to the facility so she could visually assess.After assessment it was decided to have the patient admitted to the hospital seen by internal medicine and interventional radiology for further care and management of pain.Dates of use: (b)(6) 2017.Diagnosis or reason for use: continuous nerve catheter for post op pain management.".

• Brand Name: ON-Q QUIKBLOC OVER-THE-NEEDLE CATHETER SETS
• 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: 6655957
• MDR Text Key: 78019347
• Report Number: 3006646024-2017-00014
• 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: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB100ST
• Device Catalogue Number: 104079201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR