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

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/11/2017

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6969959
• MDR Text Key: 90756072
• Report Number: 2026095-2017-00182
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30680651136207
• UDI-Public: 30680651136207
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/29/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1