Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: customer returned (1) loose 1/2cc, 6mm syringe.Customer states that very first scale mark (zero point) is marked the way too lower than it should be.The returned syringe was tested using the plug gauge and the placement of the 5 unit marking fell out of specifications.Sample will be forwarded to manufacturing (holdrege) for further review.Unable to perform dhr check for scale misaligned due to unknown lot number.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.On 15th mar 2022, holdrege received (1) loose 0.5ml syringe from unknown batch.Once received, the sample was tested per (b)(4) using plug gauge 10301.The 5 unit line fell outside of the recessed area of the gauge which means that they scale location is questionable.Per (b)(4), if accuracy of scale location is questionable, volumetric testing is to be performed.Process summary: blank barrels are transferred from totes to a bulk hopper, the hopper then meters them into the vibratory feeder, which orients and transfers the barrels single file into the first inline feeder.The first inline feeder rail transfers to the inspection dial where short molding defects are rejected.After the inspection dial, the barrels are transferred to the second inline feeder and transitions through the corona treater terminating at the inhibit gate.At cycle start, the inhibit gate opens, introducing barrels to printer infeed dial on through the flange guide which aligns the flanges for proper registration and into the print carousel where ink images are applied.From the print carousel, the barrels are transitioned to the transfer dial and into the curing oven.The cured product exits the oven chute for transfer to the next operation.Root-cause cannot be determined due to lack of batch number information.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
|