MAUDE Adverse Event Report: MEDICAL ACTON INDUSTRIES UNIVERSAL BLOCK KIT

Model Number	83740
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident three of ten.The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.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.H3 other text : device not returned.
Event or Problem Description
Incident three of ten.The customer reported that needle is bending during procedure and noted the hole on the needle is located in the wrong position.The customer indicated there were ten different procedures impacted, this is incident three of ten.The procedures impacted include medial branch block, interlaminal, caudal, and si injections.There was no apparent patient injuries or interventions taken; however, the complaint site is not certain the procedure is fully successful given the needle hole presentation.The complaint site has indicated there were delays in procedure and concern of medication traveling to other areas of the spine that were not targeted for procedure.The patients will be further evaluated at their follow-up appointments with provider.The complaint site has indicated this was not the needle that they agreed upon during creation of the kit.
Additional Manufacturer Narrative
Three of ten.Medical action industries reviewed the production bill of material in comparison with the customer quote contract.The needle component assembled in the complaint kit does match that approved by the distribution representative (contracted selling partner) and matches the contract.The complaint needle does have an intended use that is appropriate for the convenience kit procedure.Root cause analysis concluded that there was likely a miscommunication that occurred between the final end-user preference versus the distribution partner who contracted with medical action industries on this convenience kit.The complaint needle has since been changed to an alternate needle agreed upon by the distributor representative and end-user.The reported complaint has been entered in our tracking and trending program in order to monitor for emerging trends in the marketplace.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.Device not returned.

• Brand Name: UNIVERSAL BLOCK KIT
• Common Device Name: UNIVERSAL BLOCK KIT
• Manufacturer (Section D): MEDICAL ACTON INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTON INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole early ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 19202891
• Report Number: 1030451-2024-00003
• Device Sequence Number: 12767779
• Product Code: LRO
• UDI-Device Identifier: 10809160412480
• UDI-Public: 10809160412480
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 83740
• Device Catalogue Number: 83740
• Device Lot Number: 317629
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown