MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN; EQUIPMENT COVERS

Model Number	42216NS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 15jul2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.O&m halyard, inc.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
During a retrospective review with the fda esg help desk it was determined that this complaint was sent to the test region and not the fda production region; therefore, this complaint is being submitted to the production region on 15jul2019.O&m halyard, inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 3005997949-2019-00001 for the first patient-avid mdr number 1047429-2019-00008.Refer to 3005997949-2019-00003 for the third patient-avid mdr number 1047429-2019-00010.Refer to 3005997949-2019-00004 for the fourth patient-avid mdr number 1047429-2019-00011.Refer to 3005997949-2019-00005 for the fifth patient-avid mdr number 1047429-2019-00012.The customer reported the back-table cover is leaving loose fibers on the sterile field and in the patient's eyes.There was no patient injury reported.No additional information was received.
Additional Manufacturer Narrative
Correction, submission name: (b)(4)_3005997949-2019-00001_back table cover correction, date sample returned: 04jun2019.Two (2) swatches were returned of the back-table cover (btc) material - paper clipped to a piece of paper with what appears to be the product information.The lot number listed on the paper matches the lot number reported.No full-size samples were received.There are handwritten words on the sample swatches stating, "new pack" therefore the sample type listed above is considered "representative".No product packaging was received.The two (2) swatches of btc material were evaluated under ambient light conditions.The swatches of btc material measure at least 4" x 4" however the edges are not straight, and the shape of the swatches is irregular.Both swatches arrived with the handwritten words "new pack" written in pencil along one edge.No visual lint, particulates, stains, discoloration or any abrasion is observed on the nonwoven side.No visual damages are observed on the film side.A representative area of both swatches was viewed under magnification on both sides.No lint, particulates, stains, discoloration or any abrasion is observed on the nonwoven side.No visual damages are observed on the film side.Based on the device history record for lot number ac9029081 representative swatches and pictures were provided for evaluation/ observation and incident was not confirmed.Per process assessment and review of complaint trends, a root cause was not identified for the reported incident; and no corrective actions taken.The reported particles are white.We will continue to closely monitor the field performance of this product through complaints review board (crb) monthly to identify emerging trends and if applicable, additional investigations will be initiated and corrective action taken if indicated.All information reasonably known as of 01aug2019 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 o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.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.

• Common Device Name: EQUIPMENT COVERS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8788575
• Report Number: 3005997949-2019-00002
• Device Sequence Number: 19413528
• Product Code: PUI
• UDI-Device Identifier: 30680651422164
• UDI-Public: 30680651422164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: D320421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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 Expiration Date: 01/29/2024
• Device Model Number: 42216NS
• Device Catalogue Number: 104221600
• Device Lot Number: AC9029081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1