MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* EXPANSION KITS WITH SOAKER* CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G; CATHETERS

Model Number PM020-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/11/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device is reported to be available but has not yet been returned.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 30-nov-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).

Event Description

Fill volume: 125 ml, flow rate: unknown, procedure: total knee replacement, cathplace: posterior capsule of his knee.It was reported that catheter break occurred.The catheter was placed by the orthopedic surgeon, following a total knee replacement on (b)(6) 2017.The nurse met resistance when trying to remove the catheter and the physician assistant was present while the break occurred.The patient was stable and was discharged with a piece of catheter left in his posterior capsule of his knee.Additional information received 13-nov-2017 stated the patient experienced discomfort as the nurse pulled the catheter, the nurse massaged the skin to help release catheter.About 5 inches of the catheter was retained in the patient.No part of the catheter appeared grayish during removal.No additional information required.

Manufacturer Narrative

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).

Manufacturer Narrative

One sample device was returned.The silversoaker catheter was returned not fully intact.It was missing the black distal tip.A visual observation found that the proximal end of the catheter near the luer connector as the distal end near the tip were stretched.Three distinct kinks were observed and measure with a caliper.The first one measured 222.48mm from the proximal end of the catheter.The second kink was at 259.30 and the third at 353.57mm from the proximal catheter end.The catheter was examined under a microscope magnified at 1.6x, and confirmed the missing distal black tip and observed the second kink.Tensile strength was performed on the catheter using the instron machine.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the catheter mid-body segment was 9.23(lbf).The infusion segment was 7.63(lbf).The catheter met specifications during the tensile test and no additional testing was performed.The investigation summary concluded that the soaker catheter was received not fully intact, missing the infusion segment.Evidence revealed that stretching was observed before the breakage.Tensile strength was performed on the mid-body segment and met specifications.Excessive force failure mode was chosen because during visual observation of the catheter, stretching and breakage was observed.Tensile strength on the mid-body met specifications.Using excessive force >4.00(lbf) on the catheter at the mid-body segment and >2.8(lbf) at the infusion segment will cause it to break.All information reasonably known as of 09-feb-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: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7076855
• MDR Text Key: 94897349
• Report Number: 2026095-2017-00202
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (y/n): N
• PMA/PMN Number: K043456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Date Manufacturer Received: 01/22/2018
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 88