MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH SOAKER* CATHETER, 400 ML,; CATHETERS

Model Number	PS6507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
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, 0202393875, 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 06-may-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.
Event or Problem Description
A report was received from (b)(6) stating a catheter snapped underneath the skin during an arthroscopic shoulder decompression.There was no reported injury but a secondary surgery was scheduled to remove the catheter.Additional information received 26-apr-2017 stating that the catheter was sutured through and was broke inside of the patient.A secondary surgery was scheduled to remove the catheter.Additional information received 27-apr-2017 stating this occurred during removal of the catheter.No additional information was provided.
Additional Manufacturer Narrative
Device procode: bso.All information reasonably known as of 05-jul-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).

• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6559512
• Report Number: 2026095-2017-00080
• Device Sequence Number: 992322
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• 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): 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: PS6507
• Device Catalogue Number: 101365900
• Device Lot Number: 0202393875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other