MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL UTILITY DRAPE W/TAPE 2; SURGICAL DRAPES AND PACKS

Model Number	89731
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer noted there was linting from the drape into the patient's eyes.She stated that the issue was resolved by using a saline wash to remove the lint.No injury or long-term effects were reported as a result of the issue.
Additional Manufacturer Narrative
The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the o&m halyard, inc.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 o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.
Additional Manufacturer Narrative
One (1) representative sample received unopened and unused.Product packaging was received.The sample was evaluated under ambient light conditions.The sample arrived in a sealed product package.There are no visual damages observed on the package, front or back.The package was opened and the csr wrap with the utility drapes was inspected.No lint or fibers were observed inside the open package, on the csr wrap or on the lab table.The csr wrap was unfolded, and the two utility drapes were opened and laid out on the lab table.During the unfolding and manipulation of the utility drapes, no lint or fibers were observed to detach from the samples.The samples were inspected on both sides.No loose lint or fibers were observed.The release tapes were peeled away from the adhesive strips.No loose fibers were observed.All edges of the release tapes appear smooth.Both samples were gently shaken, no lint or loose fibers were observed to detach from either drape.The complaint of linting could not be replicated.The dhr (device history record) were reviewed and no abnormalities were found.Current process was reviewed and no abnormalities were reported during the manufacturing of this product.The investigation for this event was based on the information provided as well as sample evaluation results.No root cause was identified this product incident is documented in the o&m halyard, inc.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 o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: SURGICAL UTILITY DRAPE W/TAPE 2
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq.; blvd. luis donaldo colosio; col.educativa, nogales sonora 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16985453
• Report Number: 3005997949-2023-00002
• Device Sequence Number: 6762521
• Product Code: PUI
• UDI-Device Identifier: 30680651897313
• UDI-Public: 30680651897313
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 89731
• Device Catalogue Number: 991089731
• Device Lot Number: AC2229401G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown