MAUDE Adverse Event Report: AVID MEDICAL, INC. GENERAL SURGICAL PROCEDURE KIT

Model Number	SINA234
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.The root cause of the nonconformance could not be identified due to limited information provided by reporter.There was no lot number or component identification provided after multiple inquiries.There is no picc trim tool included in the kit reference provided.There is no history of similar complaints received.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 product is defective or has caused serious injury.
Event or Problem Description
A picc line sterile setup was completed per protocol.After catheter was cut with trim tool (that comes with picc line catheter kit), the line was flushed with nss numerous times to check for any defects; none were noted before insertion.After access was gained, picc catheter was threaded through the transducer with forceps (splinter, 4.5 fine point) that are included in the neonatal procedure picc pack.Once line was threaded and transduced was removed, line was flushed and noted to be leaking at the insertion site.The line was repositioned and flushed again; leak was still observed.The physician was notified of the leak and came to the patient's bedside.The line was pulled back approximately 3 cm and a hole was noted in the catheter and the line was removed from the patient.Additional information was requested on october 10, 2024, october 14, 2024, and october 16, 2024, with no response received from the customer.

• Brand Name: GENERAL SURGICAL PROCEDURE KIT
• Common Device Name: GENERAL SURGICAL PROCEDURE KIT
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; stonehouse commerce park; toano, VA 23168
• Manufacturer (Section G): AVID MEDICAL, INC.; 9000 westmont drive; toano, VA 23168
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano,, VA 23168 ; 8287820529
• MDR Report Key: 20547518
• Report Number: 1047429-2024-00005
• Device Sequence Number: 7988241
• Product Code: LRO
• UDI-Device Identifier: 10809160326596
• UDI-Public: 10809160326596
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 10/28/2024

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: SINA234
• Device Catalogue Number: SINA234
• Device Lot Number: UNKNOWN
• 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: 10/07/2024
• Initial Report FDA Received Date: 10/28/2024
• 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
• Patient Sex: Unknown