MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM QUIKBLOC OVER-THE-NEEDLE CATHETER SET, STIMULATING; REGIONAL ANESTHESIA

Model Number	TBT02100T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0202966556, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 11-oct-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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: tap block.Cathplace: tap block.It was reported the anesthesiologist was performing a tap block and when he tried to remove the stylet from the t-bloc catheter he could not pull back the stylet and had to perform the procedure again with a new tray.Additional information received 13-sep-2018 stated the catheter was sheared when the physician attempted to remove the needle.As he pulled the needle out and met resistance, the catheter sheared.
Additional Manufacturer Narrative
One sample device was returned.The returned catheter was examined.During examination, it was observed that the accompanying stylet was severely twisted.This twisting was in a coil-like shape.The returned catheter coating was sheared approximately 7" from the catheter's distal end.The catheter's internal spring remained fully intact.The catheter shear appeared to be jagged in form and not sheared cleanly as would be expected if the device were cut by a sharp object (i.E.Needle tip).The damage observed to the returned stylet appeared to have derived from the catheter possibly being wrapped around the end-users finger or another object while tension was being applied to the stylet catheter.The tensile test was completed, yielding a result that exceeded the minimum standard.Based on the available information, the possible root cause is the styletted catheter may have become snagged on an internal structure after placement and was subsequently damaged during an attempt to remove the catheter.The root cause was inappropriate use.All information reasonably known as of 30-nov-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 avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).

• Brand Name: ON-Q PAIN RELIEF SYSTEM QUIKBLOC OVER-THE-NEEDLE CATHETER SET, STIMULATING
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7959860
• Report Number: 3006646024-2018-00035
• Device Sequence Number: 13766907
• Product Code: BSO
• UDI-Device Identifier: 30680651407840
• UDI-Public: 30680651407840
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: TBT02100T
• Device Catalogue Number: 104078403
• Device Lot Number: 0202966556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1