MAUDE Adverse Event Report: HALYARD HEALTH SAF-T-PEXY* T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number 98701

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2018 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).Device not returned.

Event Description

It was reported that a patient experienced an incident with gastrointestinal t-fasteners separating prematurely.Additional information received on (b)(6) 2018 stated that there was patient injury and an internal investigation is in progress.The sample was discarded and information on any medical intervention was not available.No further information was provided.

Manufacturer Narrative

The device history record for the reported lot number, aa7144r01, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.It is not possible to determine the root cause of the reported issue without a sample as a proper evaluation could not be performed in order to confirm or duplicate the reported incident.All information reasonably known as of 27-mar-2018 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).

• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7321301
• MDR Text Key: 102079440
• Report Number: 9611594-2018-00022
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10680651987010
• UDI-Public: 10680651987010
• Combination Product (y/n): N
• PMA/PMN Number: K093312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 98701
• Device Catalogue Number: 991098701
• Device Lot Number: AA7144R01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Patient Sequence Number: 1