MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH SOAKER* CATHETER, 270 ML, 5 ML/HR, 2.5 IN./65 MM; CATHETERS

Model Number	PS6504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2018
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, 0202651724, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 28-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).Device not returned.
Event or Problem Description
Fill volume: n/a.Flow rate: n/a.Procedure: unknown.Cathplace: wound bed.It was reported that a catheter broke inside of a patient during removal, and was required to go back into surgery for removal.Additional information received on 19-feb-2018 from (b)(6) adverse incident report (b)(6) stated that the date of the incident was (b)(6) 2018.It was stated that "soaker catheter laying in wound bed snapped during removal, leaving significant portion inside patient." the patient was required to return to surgery have an re-opening of the original suture line in order to remove the retained section of broken catheter under general anesthesia.The patient's return to surgery was uneventful and plans for patient discharge was not pushed back.It was noted that there were no indication of problems during initial catheter insertion, nor during use or the initial stages of removal.The staff was stated to be familiar with the product.No further information was received.
Additional Manufacturer Narrative
Additional information received.All information reasonably known as of 29-mar-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).
Event or Problem Description
Fill volume: n/a.Flow rate: n/a.Procedure: rt breast delayed diep flap reconstruction using micro surgery and tapp block on (b)(6) 2018.Cathplace: abdomen/ within the rectus sheath.Additional information received on 14-mar-2018 stated that the catheter was removed on (b)(6) 2018 and the event occurred during catheter removal.It snapped during removal with approximately 25 cm retained inside the patient, and was identified via ultrasound.The patient was required to return to surgery on (b)(6) 2018 to have the wound re-opened in order to removal the catheter under general anesthetic.The patient's status is good, and has been discharged home.

• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7310743
• Report Number: 2026095-2018-00028
• Device Sequence Number: 19168084
• Product Code: MEB
• UDI-Device Identifier: 30680651136566
• UDI-Public: 30680651136566
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: 08/20/2019
• Device Model Number: PS6504
• Device Catalogue Number: 101365602
• Device Lot Number: 0202651724
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/04/2018
• Patient Sequence Number: 1
• Patient Age: 48 YR