MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. INTRATHECAL CATHETER

Model Number	11830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Impaired Healing (2378); Skin Inflammation/ Irritation (4545)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the catheter revision kit, verification of all final testing performed by/on the catheter revision kit, verification of sterilization, and packaging for subject catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter revision kit function.Device was discarded and not returned for additional evaluation and investigation.It was determined that the catheter was exposed due to the patient's incision not healing.Clinical specialist (cs) stated that the patient is very thin and doesn't have a lot of skin.Cs stated that the patient has an area of skin that isn't healing because of an area of deadened tissue.Physician reportedly does not know exactly what caused the issue.Please note, this patient has had prior issues captured in mfr 3010079947-2021-00054, mfr 3010079947-2021-00055, mfr 3010079947-2021-00080.Internal complaint number: (b)(4).
Event or Problem Description
Information was provided that reported a catheter revision occurred due to the catheter being exposed.Patient initially presented with redness and low back pain.The patient had about two centimeters of tissue removed from the catheter site and no discharge was noted.The incision was then closed.Additional communication confirmed that the patient's catheter was replaced due to the tissue deadening and wound dehiscence, leading to the exposure.The original catheter was discarded after the replacement surgery.

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 12127738
• Report Number: 3010079947-2021-00192
• Device Sequence Number: 17026600
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)221106(10)27172
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 27172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention