MAUDE Adverse Event Report: HALYARD - IRVINE QUIKBLOC OVER-THE-NEEDLE CATHETER SET 4IN STIM; CATHETER, CONDUCTION, ANESTHETIC

Model Number QB10016SGC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

Procedure: interscalene nerve block.Cathplace: interscalene nerve block.It was reported by our clinical specialist that an incident of a catheter shearing occurred during an interscalene nerve block.It was reported that the catheter was inserted inside the patient and the needle removed.The anesthesiologist wanted to change the position of the catheter, so the doctor reinserted the needle into the catheter; the catheter was sheared during this process.The catheter tip was broken inside the patient.As the catheter tip was visible out of the patient's skin, the anesthesiologist was able to remove the broken catheter without any remaining catheter pieces being left inside the patient.A new catheter set was opened and the interscalene nerve block procedure was completed and no further issues occurred with the new catheter set.No patient injury occurred as a result of the reported incident.It was reported that no further patient information will be provided by the hospital.Anp: asked not provided.

Manufacturer Narrative

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.The instructions for use (ifu) (14-60-798-0-01) indicate, "warning: to avoid damaging the catheter, never reinsert the needle through the catheter after the catheter is placed." 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: QUIKBLOC OVER-THE-NEEDLE CATHETER SET 4IN STIM
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): HALYARD - IRVINE; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4469232
• MDR Text Key: 15317739
• Report Number: 2026095-2015-00028
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: QB10016SGC
• Device Catalogue Number: 104305700
• Device Lot Number: 0202028792
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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
• Treatment: DRUG: UNKNOWN - ANP