MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,10",EXP KT,-,OQ,5; INCISIONAL ACCESSORY KITS

Model Number	PM040-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: the actual device was not returned.A review of the device history record is not possible as no lot number was provided.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.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: unknown.Flow rate: unknown.Procedure: unknown.Catheter place: unknown.It was reported that a patient catheter broke inside the patient.It was determined that catheter remnant inside the patient would be left as it was since the risk of removing it was greater than the benefit for this patient.No additional information provided.

• Brand Name: SURGPN,10",EXP KT,-,OQ,5
• Common Device Name: INCISIONAL ACCESSORY KITS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6189697
• Report Number: 2026095-2016-00227
• Device Sequence Number: 16367099
• Product Code: MEB
• UDI-Device Identifier: 30680651135392
• UDI-Public: 30680651135392
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2016

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 Model Number: PM040-A
• Device Catalogue Number: 101353900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 12/20/2016
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 84