MAUDE Adverse Event Report: O&M HALYARD, INC. EYE DRAPE WITH DOUBLE POUCH 55 IN. X 76 IN.; SURGICAL DRAPES

Model Number	76346
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident two of two the product involved in this event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product.The product is contract manufactured by principle & will biotech (pinghu) co., ltd.(fda registration number 3006973666).A scar was issued to the contract manufacturer on july 3, 2024.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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Incident two of two complaints from the same end-user were received regarding drape product 76346.The glue residue of the drape was on the patient's eye during intra ocular lens implantation surgery'.Additional information was requested regarding the incident, but the patient impact was unknown.No lot number was provided or known by the reporter.
Additional Manufacturer Narrative
Incident two of two.A sample or photo was not provided for investigation.The components were assembled by using double-sided tape.No hot-melt or cold glue was used on this drape.The customer did not provide a complaint lot number; therefore, the manufacturing site cannot review device history records including inspection documentation.Complaint database was reviewed (b)(6) 2023 - (b)(6) 2024, there are no other complaints of this nature found.A root cause was not identified.The following corrective actions have been identified for implementation to minimize opportunity for recurrence: employees were trained on the following preventive measures: 1.Iqc should carefully inspect incoming materials as per the material incoming inspection work instruction and report any anomalies immediately.2.Employees must be vigilant during production, report any glue residue to management.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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: EYE DRAPE WITH DOUBLE POUCH 55 IN. X 76 IN.
• Common Device Name: SURGICAL DRAPES
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): PRINCIPLE & WILL BIOTECH (PINGHU) CO., LTD.; no. 2000 xing ping 2nd road; economic development zone; pinghu city zhejiang, china 31420 0; CH 314200
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19826314
• Report Number: 3014421917-2024-00008
• Device Sequence Number: 8695002
• Product Code: PUI
• UDI-Device Identifier: 30680651763465
• UDI-Public: 30680651763465
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 76346
• Device Catalogue Number: 991076346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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