MAUDE Adverse Event Report: O&M HALYARD, INC. CUSTOM DISPOSABLE U-SHEET 76X120 190; SURGICAL DRAPES AND PACKS

Model Number	13231
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical drape material is coming off.Bits of the material have become loose on the surgical field as a result.The end user's hands and arms are in contact with the drape.The surgeon and or staff are concerned that the debris may come in contact with the surgical incision.
Additional Manufacturer Narrative
The product involved in the report was not available for evaluation.Upon completion of the investigation, a follow-up report will be filed.All information reasonably known as of25apr2023 has been included in this medical device report.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 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
The product involved in the report was not returned for evaluation.Based on the investigation no root causes can be established, as a lot number, sample or photo was not provided.This is an isolated event and personnel was notified about the issue to create awareness.All information reasonably known as of 15jun2023 has been included in this medical device report.This product incident is documented in the 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 product is defective or has caused serious injury.

• Brand Name: CUSTOM DISPOSABLE U-SHEET 76X120 190
• 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 NG 3 AND NG 5; av. hidalgo no. 6 esq blvd; luis donaldo colosio; col.educativa,nogales sonora, mexico 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16812352
• Report Number: 3005997949-2023-00001
• Device Sequence Number: 5780859
• Product Code: PUI
• UDI-Device Identifier: 30680651132315
• UDI-Public: 30680651132315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: Other
• Device Model Number: 13231
• Device Catalogue Number: 991013231
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown