MAUDE Adverse Event Report: O&M HALYARD, INC. STANDARD BACK TABLE COVER, 50 IN. X 90 IN. / 127 CM X 228 CM; EQUIPMENT COVERS

Model Number	42216NS
Medical Device Problem Codes	Material Frayed (1262); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 24jul2019 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.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
O&m halyard, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 3005997949-2019-00014 for the second patient.It was reported that the "back table covers have lint on them and they are being used in cataract cases." additional information was received on 3-jul-2019 that states two patients had lint in the surgical site and eyes and a follow up procedure for irrigation was performed.Additional information was requested.
Event or Problem Description
O&m halyard, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 3005997949-2019-00014 for the second patient.It was reported that the "back table covers have lint on them and they are being used in cataract cases." additional information was received on 3-jul-2019 that states two patients had lint in the surgical site and eyes and a follow up procedure for irrigation was performed.Additional information was requested.
Additional Manufacturer Narrative
The fal received one (1) open, unused cataract pack with the pack components wrapped inside a back table cover (btc).An itemized list of components was included inside the pack.No other packaging was received.The sample was evaluated under ambient light conditions.The pack arrived in an open product package.There are pack components sealed in a pouch outside the pack.These components were not evaluated as they were outside the pack.The contents of the pack were removed.The tape tabs arrived torn along the perforation lines.The pack was carefully unfolded.The back table cover was inspected for any visual damage.There are no particulates of any color observed on the nonwoven side.There is no linting or abrasion observed on the nonwoven side.There are no tears, cuts, holes or any other visual damage observed on either side of the btc.The sample was evaluated under ambient light conditions.The pack arrived in an open product package.Based on the sample results this incident was not confirmed.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 12sep2019 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.

• Brand Name: STANDARD BACK TABLE COVER, 50 IN. X 90 IN. / 127 CM X 228 CM
• Common Device Name: EQUIPMENT COVERS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta 30004
• MDR Report Key: 8832980
• Report Number: 3005997949-2019-00013
• Device Sequence Number: 18879096
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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 Model Number: 42216NS
• Device Catalogue Number: 104221600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1