MAUDE Adverse Event Report: AVID MEDICAL GENERAL SURGERY TRAY KIT; PROCUREMENT PACK

Model Number	LLOG2000-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report is not available for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 09feb2023 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 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 o&m halyard, inc.Product is defective or caused serious injury.Device not returned.
Event or Problem Description
Customer states scalpels are breaking in tissue procurement pack.There was no injury to patient or healthcare personnel.There was no injury was reported to either patient or health care personnel.(this kit is used for tissue procurement from a donor).
Additional Manufacturer Narrative
A definitive root cause could not be established as the defect device was not returned by the customer for evaluation.The scalpel manufacturer niraj industries pvt.Ltd was made aware of this issue.The complaint component 5311876 scalpel was a substitution for the regular scalpel included in the customer convenience kit.Avid medical performed an inspection which found that the this substitute scalpel was bendable near the middle where the customer experienced breaking and the blade is slightly more narrow than the one the customer was accustomed to.This component will no longer be provided as a substitution for the customer's preferred scalpel component within this convenience kit.Should additional information be obtained, a follow-up health authority report will be provided.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 o&m halyard, inc.Product is defective or caused serious injury.

• Brand Name: GENERAL SURGERY TRAY KIT
• Common Device Name: PROCUREMENT PACK
• Manufacturer (Section D): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 16513479
• Report Number: 1047429-2023-00001
• Device Sequence Number: 6239812
• Product Code: LRO
• UDI-Device Identifier: 10809160315644
• UDI-Public: 10809160315644
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: Health Professional
• Device Model Number: LLOG2000-13
• Device Catalogue Number: LLOG2000-13
• Device Lot Number: 1542772
• Was Device Available for Evaluation?: No
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/25/2023
• 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