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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (96331353) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the final investigation of the complaint device has been completed by the original equipment supplier (b)(4) medical.[conclusion]: the healthcare professional reported that during the procedure, the physician felt water leaking during the attempt to detach the coil using the trufill dcs syringe ii (635002 / 96331353).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.A comment made was that the trufill was difficult to use because ¿water keeps leaking out.¿ there was no report of any patient adverse event or complications.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a complaint was received reporting that the physician fel water leaking from the trufill dcs syringe ii during the attempt to detach the coil.The syringe was replaced with another trufill dcs syringe ii and the procedure was successfully completed.A review of manufacturing documentation associated with this lot (96331353) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.A search of our complaint history database for the same or similar complaints over the past five years showed that there were eight (8) complaints opened but the investigations did not confirm the reported issue.The complaint device was returned for evaluation.The device was contained in a pouch labeled as ¿complaint (b)(4).¿ upon receipt of the complaint device, a visual inspection was performed.It was noted that the gauge needle was in the zero position when received.The gauge face was warped / distorted on the lower right-hand side for the complaint device.It was also noted that the lot identification information that is stamped on the outside of the gauge by (b)(4)¿s gauge supplier is no longer visible on the gauge housing of the device.There was crazing noted on various areas of the housing of the device.The device plunger also exhibited discoloration.There were no anomalies noted in the visual inspections.After the visual inspection was completed, functional testing was performed.The device was connected to a pressure indicator and plunger pulled to fill the device with distilled water for aspiration.The latch was engaged and the plunger was rotated clockwise to pressurize the device.As the device was pressurized, the gauge did not respond.No leak was observed at any point during the functional testing.However, due to the gauge not responding during the pressurization of the device, further evaluation was performed on the gauge.The gauge was untorqued and removed from the complaint device.The filter was inspected under magnification.The filter exhibited crystallized corrosion.(b)(4)¿s current manufacturing controls include 100% automation testing for pressure leakage, pressure decay, vacuum decay, and gauge accuracy during manufacturing using ultra high purity nitrogen gas before leaving our facility.Devices that pass this test are marked by automation for identification.Devices that fail are not marked.The returned device was marked, indicating that it met manufacturing specifications when it left (b)(4)¿s facility.Investigation conclusion: a review of the device history record for the indicated lot confirmed that everything met the acceptance criteria.There were 25 devices functionally tested with distilled water for gauge accuracy and pressure cycled; all 25 devices tested in lot 96331353 passed the in-processed testing.The devices that are functionally tested with water are disposed of upon completion of testing.Additionally, all devices are 100% automation tested with ultra-pure nitrogen for functional compliance during manufacturing.Each device is checked for proper gauge orientation, responsiveness, pressure accuracy (from vacuum to maximum gauge capacity), and device seal integrity.The returned device exhibits cts marking, an indication of 100% functionality at the time of manufacturing.The returned device exhibits excessive crazing, an indication of extreme abuse, either from heat or chemical treatment.Additionally, the gauge fac was warped / distorted at the lower right-hand area is an indication that the device had been exposed to excessive heat.There was crystallized corrosion observed on the gauge filter; the crystallized substance corroded the gauge filter, blocks the flow of water, and prevents the gauge indication from functioning when the inflater is pressurized.This condition is observed when certain liquid compounds are left inside the filter and evaporate over time leaving mineral deposits that lead to the clogging or blocking of the filter that ultimately leads to a loss of gauge functionality.Furthermore, the lot identification externally stamped on the gauge has been worn off or removed from the gauge of the complaint device.The crazing, warped gauge face, corroded gauge filter, and worn / removed lot identification are all indicative that the device underwent multiple uses.As a reminder, (b)(4) medical products are all validated for single-use application.Based on (b)(4) medical¿s rigorous final assembly step of 100% pressure, leakage, vacuum and gauge accuracy testing, and the fact that no liquid is ever introduced in (b)(4)¿s manufacturing and testing processes for shippable finished products, (b)(4) believes that the device left our facility in a fully functional condition free of the crazing and other defects exemplary of extreme use exhibited by the returned device.Therefore, (b)(4) does not confirm this complaint and has no assignable corrective actions.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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