MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD VIDEO DRAPE 5IN - 96IN; SURGICAL DRAPES AND PACKS

Model Number	51739
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample was not available for evaluation.O&m halyard, inc.Is the initial importer and repackager/relabeller establishment of the halyard video drape 5in - 96in.The complaint product is manufactured by exact medical manufacturing, inc (fda registration number (b)(4).A supplier corrective action (scar) was submitted to the manufacturer on may 24,2024.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp(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.
Event or Problem Description
Customer reported that the node navigator was properly draped and secured with video drape.During right seed localized partial mastectomy procedure, it was noted by the surgeon that the perforated end of the video drape was separated.This caused the probe to be exposed.The procedure was extended due to having to reestablish sterile field and re-wrap the probe with drape.Staff have started relocating the probe end to another location and securing with the sterile tape provided in the drape kit.
Additional Manufacturer Narrative
* correction report: added related report number (b)(4) in h10 for medwatch received, this was omitted in error on initial report submission.* a follow-up report will be provided upon conclusion of investigation and response by the manufacturer.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-ghc-24-00315.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.
Additional Manufacturer Narrative
An actual sample or defect photo was not available.The device history record was reviewed and confirmed product was manufactured according to approved specifications.Investigation of incident found end-user was not utilizing this drape correctly.The perforated tip is meant to be removed and is not intended to serve as a sterile barrier.An o&m sales teammate is working with the customer to provide them further education on the correct drape for the intended use they are seeking.This is the first and only product complaint on this product since sales initiated in 2022.There is no trend for this issue.Complaints are monitored on a monthly basis to identify any complaint trends which require corrective action, at this time this incident appears isolated.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp (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: HALYARD VIDEO DRAPE 5IN - 96IN
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): EXACT MEDICAL MANUFACTURING, INC; 21# qingjiang road; changzhou,jiangsu, china 21300 0; CH 213000
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19557214
• Report Number: 3014421917-2024-00004
• Device Sequence Number: 4812093
• Product Code: KKX
• UDI-Device Identifier: 10680651517392
• UDI-Public: 10680651517392
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024
• Report Date (Section F): 06/18/2024

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: 51739
• Device Catalogue Number: 105173980
• Device Lot Number: 2202E197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 08/13/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/02/2024; 08/14/2024
• 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
• Date Report Sent to FDA: 06/18/2024