MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SOAKER CATHETER, 270 ML, 5 ML/HR, 5 IN./12.5 CM; CATHETERS

Model Number	PS12504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint product was not returned for evaluation.The device history record for the reported lot number 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 18-oct-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 (b)(4).The device was not returned.
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: total abdominal hysterectomy.Cathplace: abdominal region.It was reported that a patient experienced a catheter break during removal with 30-40 cm retained in the patient.The user was an experienced intensive care unit trained nurse and has used the product for years.The patient had to go back for another surgery to remove the catheter.The patient is reported to be doing fine.There was no reported patient injury.
Additional 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SOAKER CATHETER, 270 ML, 5 ML/HR, 5 IN./12.5 CM
• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6969959
• Report Number: 2026095-2017-00182
• Device Sequence Number: 10780384
• Product Code: BSO
• UDI-Device Identifier: 30680651136207
• UDI-Public: 30680651136207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2017

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: 07/20/2019
• Device Model Number: PS12504
• Device Catalogue Number: 101364602
• Device Lot Number: 0202619332
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/29/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/22/2017
• Patient Sequence Number: 1