MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* ELASTOMERIC PUMP, FIXED FLOW, 400 ML X 4 ML/HR; CATHETERS

Model Number	P400X4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202775527, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.All information reasonably known as of 27-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.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).
Event or Problem Description
Fill volume: n/a, flow rate: n/a, procedure: right knee replacement, cathplace: above knee.It was reported that a catheter broke inside a patient during removal.A home health registered nurse (rn) was removing the pump from a patient and noted that it may have bin a bit hard to get out than usual.The rn was steadily pulling firmer, but nothing too unusual, but then began to start see the black markers before she and the patient heard a snap.The catheter then came out without a tip.They phoned the doctor and it was stated by the doctor "there's nothing i can do about it but just wait and see." additional information received stated that the catheter was inserted above the right knee lateral site.The patient attempted to remove the catheter himself on (b)(6) 2018, but experienced resistance.The rn had the patient change positions, warm the area, and when the catheter came out, it snapped.The removed piece was measured and was 7 cm from the first dot.The rn returned to see the patient a week later and noted that he was doing okay.It was decided that no surgery was required to removed the broken remnant.No x-ray was performed.No further information was provided.
Additional Manufacturer Narrative
One sample device was returned for evaluation.A visual inspection found a silver-soaker catheter was returned for evaluation.The distal tip was missing.When viewed under magnification it appeared to have been pulled.There was evidence of stretching at the 2nd marking and continues throughout the catheter where the breakage occurred.The breakage occurred right before the infusion segment.The damaged part was measured to be 0.030¿ near the first marking and the non-damaged part was measured to be 0.042¿.The catheter was examined under a microscope magnified at 1x, no signs of brittleness were observed.Tensile strength was performed on the silver-soaker 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 is 10.34(lbf).The result for the infusion segment was not returned and could not be tested.The catheter at the mid body met specifications during the tensile test and no additional testing was performed.The investigation summary concludes that silver-soaker catheter was damaged and received not fully intact.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.Root cause could not be determined.All information reasonably known as of 14-may-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Additional Manufacturer Narrative
Sample received.All information reasonably known as of (b)(6) 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).

• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7313878
• Report Number: 2026095-2018-00021
• Device Sequence Number: 19283043
• Product Code: MEB
• UDI-Device Identifier: 30680651136764
• UDI-Public: 30680651136764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2018

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: Nurse
• Device Expiration Date: 01/25/2020
• Device Model Number: P400X4
• Device Catalogue Number: 101367503
• Device Lot Number: 0202775527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/02/2018; 04/23/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/29/2018; 05/16/2018
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 98