MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUJECT VARIABLE INJECTION NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	G22525
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the products said to be involved were returned in a white plastic bag with two open pouches from the lot number provided in the report.The labels match the products returned.Our laboratory evaluation of the products said to be involved confirmed the report.The first device was returned in a coiled position with the adjustment wheel threaded and the handle retracted.A visual examination confirmed the winged adapter on the handle was broken.The second device was returned in a coiled position on the packaging board with the adjustment wheel threaded and the handle retracted.A visual examination confirmed the winged adapter on the handle was broken.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our laboratory evaluation of the returned devices confirmed the report.A definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Breakage of the winged adapter can occur if excessive pressure is applied to the syringe during system preparations.Prior to distribution, all acuject variable injection needles are subjected to a functional test to ensure proper needle extension and a visual inspection to ensure the product is free of kinks and/or bends.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
In preparation for a procedure, the physician selected two (2) cook acuject variable injection needles.It was reported that the physician opened the two (2) packages and found both devices with end broken [handle broken - unable to inject], user changed to another new device to continue the procedure.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: ACUJECT VARIABLE INJECTION NEEDLE
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 24028684
• Report Number: 1037905-2026-00022
• Device Sequence Number: 21082195
• Product Code: FBK
• UDI-Device Identifier: 00827002225251
• UDI-Public: (01)00827002225251(17)271008(10)W4877261
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K190829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: G22525
• Device Catalogue Number: VIN-23
• Device Lot Number: W4877261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 30 KG