MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM T-BLOC ULTRASOUND NERVE BLOCK PREP TRAY; REGIONAL ANESTHESIA

Model Number	N/A
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, ¿our fellow had a needle stick yesterday.¿ per additional information received on 24sep2024, ¿our trainees experienced a needle stick while using our avanos catheter kit for a nerve block.We have reached out multiple times regarding our concern about the flimsy nature of the foam in the catheter kit - the fact that it's loose in the kit and doesn't have a hard backing means needles easily puncture through the foam.¿ per additional information received on 25sep2024, ¿patient¿s hiv panel was inconclusive.The health care professional (hcp) started post-exposure prophylaxis (pep) for 1 week while waiting for conformation testing to be completed.¿ the fingerstick occurred after patient use.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.A root cause could not be determined.All information reasonably known as of 16 oct 2024 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 avanos medical 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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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 an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q PAIN RELIEF SYSTEM T-BLOC ULTRASOUND NERVE BLOCK PREP TRAY
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20466832
• Report Number: 3006646024-2024-00031
• Device Sequence Number: 7519612
• Product Code: CAZ
• UDI-Device Identifier: 00193494407896
• UDI-Public: (01)00193494407896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073187
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: N/A
• Device Catalogue Number: TBT02
• Device Lot Number: UNKNOWN
• 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: 09/20/2024
• Initial Report FDA Received Date: 10/16/2024
• 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