MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN INTRODUCER

Model Number	UNKNOWN
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned.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.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.All information reasonably known as of 18-apr-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.(b)(4).
Event or Problem Description
Procedure: proctectomy low anterior colon resection, right superficial abdomen.It was reported that a sheath broke off in the patient and 4 inches of the sheath was retained inside the patient.The surgeon attempted removal, but was unsuccessful.The incident was noted to have occurred during the peeling of the sheath.No further information was provided.
Additional Manufacturer Narrative
The lot number and corresponding manufacture and expiration dates provided in the initial report were provided by the complainant, but per further review, were determined to be for a different product.The lot number for the reported device is currently unknown.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: UNKNOWN INTRODUCER
• Common Device Name: UNKNOWN INTRODUCER
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6503367
• Report Number: 2026095-2017-00060
• Device Sequence Number: 7439
• Product Code: MEB
• UDI-Device Identifier: 30680651136764
• UDI-Public: 30680651136764
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: Other
• Device Expiration Date: 05/15/2019
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 06/16/2017
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 74