|
As reported by the user facility information by bbm sales organization in china: "broken off-high withdrawal force".According to the customer: description of event: on (b)(6), 2023, the patient needed indwelling needle in right radial artery for injection of drugs during operation, which was normal during injection.The indwelling needle in radial artery could be removed after postoperative resuscitation, but the anterior end of introducer puncture needle was found to be incomplete during compression hemostasis, which was reported to the doctor for examination.Ultrasonography revealed that the stump was suspected to remain in the radial artery, and radial artery exploration was immediately performed to remove the stump.Description of root cause analysis (by reporter):1.Quality problems of indwelling needle 2.Overlapping of arterial catheter with venous catheter adhesive film, high resistance to extubation 3.Wrist bending, prolonged bending of the introducer puncture needle, increasing the risk of fracture preliminary handling of event: after b-ultrasonography, radial artery exploration was performed to remove the stump.
|
|
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Broken off-high withdrawal force.From cc - notification (b)(4).Defect loc./ defect type.Qc3xhccu 1188 needle tip / qc3xhccu 024 broken off.Qc3xhccu 1001 product / qc3xhccu 114 high withdrawal force.Long text: (b)(6) 2023 08:55:09 (b)(6), phone (b)(6).Description of malfunction/failure:catheter tip broke off in radial artery description of event:on (b)(6), 2023, the patient needed indwelling needle in right radial artery for injection of drugs during operation, which was normal during injection.The indwelling needle in radial artery could be removed after postoperative resuscitation, but the anterior end of introducer puncture needle was found to be incomplete during compression hemostasis, which was reported to the doctor for examination.Ultrasonography revealed that the stump was suspected to remain in the radial artery, and radial artery exploration was immediately performed to remove the stump.Description of root cause analysis (by reporter):1.Quality problems of indwelling needle 2.Overlapping of arterial catheter with venous catheter adhesive film, high resistance to extubation 3.Wrist bending, prolonged bending of the introducer puncture needle, increasing the risk of fracture preliminary handling of event:after b-ultrasonography, radial artery exploration was performed to remove the stump.No futher information: no activity available: task: calculation similar cases: status: task completed.Task: calculation similar cases: status: task completed.Item 1: problem: damage - tear off.Bmi complaint management dated 2023-11-10.Device history record (dhr): reviewed the device history record for batch number 22k03g8261 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no samples returned and no photos provided for this notification.Further evaluation and investigation cannot be concluded.This complaint however, shall be taken to the knowledge and filed for statistical purpose.Nevertheless, if the complaint sample is available and being returned, hence complaint will be re-open and re-investigated accordingly.Note: complaint flow to production.Objectpart capillary.Task for (b)(6): review of batch history records.Status: task completed.Dhr reviewed.Task for (b)(6): no sample(s).Status: task completed.No samples or pictures available.Task for (b)(6): awaiting statement.Status: task completed.Root cause analysis: machine.Production completion date.(b)(4).Process cards show no abnormalities.Problem analysis[?][?] limited defect mode described in the complaint description which is it only stated, "anterior end of introducer puncture needle was found to be incomplete during compression hemostasis ".However, there was no further information on the method of handling the product.No sample or picture of the defect mode was provided for further evaluation.[?] process analysis: the process mapping for catheter assembly line (cal) and end control machine (ecm) for introcan has been reviewed and such defect shall be detected during catheter present check station, catheter tip inspection station and trim length, bevel & contour vision inspection station.Tear-off/broken capillary will result in lost detection of the catheter tip.This will be automatically rejected by the inline vision camera by both processes cal and ecm.Cal process flow.Ecm process flow.All the in-line test equipment is subject to frequent calibration and regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in time and would be mitigated immediately.In-process quality controls and final controls on a random sample, basis was conducted by different teams along the production process.Herewith any systematic product defect would be detected.The venipuncture was simulated, and blood is visible in the cannula hub chamber in picture 1.Then, the catheter was advanced off the needle picture 2, assuming that no blood was visible in the catheter (no second flashback).Try to reinsert the cannula back into the vein which possibly could result in a cut of the catheter as in picture 3.There is a possibility that the catheter could be cut off as communicated in ifu: warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Do not bend the catheter/needle during insertion, advancement, or removal of the needle.Extreme care should be taken not to cut the catheter and possibly cause an embolism.Manufacturing control[?][?] all the products are subjected to in-process quality controls and final controls inspection on a random sample basis which has been conducted by different teams on a regular basis within the production process to ensure the product are free from any damages.Herewith a systematic product defect would be detected.[?][?] [?] batch analysis.Visual inspection.· specification for capillary surface: no damages such as split, kinks, bumps or scratches are accepted.· specification for capillary tip: no damages on capillary tip whereby no cracks, notches or similar defects can be observed and free of plastic chips.· there shall be no damages on the overall product condition · the complaint batch passed all the above test and showed no abnormalities.Summary of root cause analysis: as the affected sample or any picture was not provided, further evaluation is not possible.Hence the root cause could not be determined cause : cause could not be determined.Damaged catheter-tear off/broken does not appear to be attributed to the manufacturing process as the defect is able to be detected and rejected by the in-line vision systems of the equipment.Damages induced after the assembly process is not possible since the catheter has been protected with the protective cap.This complaint most likely does not appear to be attributed to the manufacturing process as all the products are manufactured in accordance with product specification - introcan® (rmf-120-001-ps-01) and conformed to the requirement of iso standard.All the product manufactured is subjected to and must be passed all the in-process and final control inspection.Device history record review showed no deviation at the in-process and final control inspection.The actual sample involved in the event was not available for evaluation.Without the actual sample and picture, further evaluation was not possible, and the exact cause of the event could not be determined.Therefore, this complaint is concluded not confirmed.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.
|
