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Unit was defective due to a "hole in the balloon" [device defective] device leakage [device leakage] 'no additional ae/pqc reported [no adverse event] case narrative: this spontaneous report originating from united states was received from a other (facility) via clinical account specialist (cas), referring to a female patient of unknown age.The patient's concurrent conditions included asthma.The patient's medical history, concomitant medications, and drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # 1087342 and expiration date were reported as 22-may-2026) via unknown route for unknown indication.Clinical account specialist reported that he was informed by a materials manager that a vacuum-induced hemorrhage control system (jada system) unit was defective due to a hole in the balloon (device defective).Materials manager reported that the hole caused leaking (device leakage) when the balloon was being inflated, therefore the unit could not be used.The vacuum-induced hemorrhage control system (jada system was available for inspection or retrieval.No additional adverse event/product quality complaint reported (no adverse event).Upon internal review, the event device defective was considered to be medically significant.Medical device reporting criteria: malfunction.
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Complaint sample is not available for investigation.Review elements of the event included lot record package (dhr), non-conformances, manufacturing controls, capa log and complaint trends.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.In process and finished product testing is performed and approved prior to release.Based on the information received, there is no indication that the device malfunctioned.If the complaint sample becomes available, this complaint will be re-opened and additional investigation may be performed.
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Unit was defective due to a "hole in the balloon" [device defective] device leakage [device leakage] 'no additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a other (facility) via clinical account specialist (cas), referring to a female patient of unknown age.The patient's concurrent conditions included asthma.The patient's medical history, concomitant medications, and drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # 1087342 and expiration date were reported as 22-may-2026) via unknown route for unknown indication.Clinical account specialist reported that he was informed by a materials manager that a vacuum-induced hemorrhage control system (jada system) unit was defective due to a hole in the balloon (device defective).Materials manager reported that the hole caused leaking (device leakage) when the balloon was being inflated, therefore the unit could not be used.The vacuum-induced hemorrhage control system (jada system) was available for inspection or retrieval.No additional adverse event/product quality complaint reported (no adverse event).Upon internal review, the event device defective was considered to be medically significant.Medical device reporting criteria: malfunction.Follow up information was received from other (facility) via clinical account specialist (cas) on 29-feb-2024.The vacuum-induced hemorrhage control system (jada system) unit was not broken.Balloon had a pre-existing hole which caused inflation to fail.Fluid (water) was squirting out of the hole and unit could not be used.Operator of device was health professional.It was reported that the vacuum-induced hemorrhage control system (jada system) will not be inspected for this case and can be discarded as per protocol.Follow up information was received on 25-mar-2024.Executive summary vacuum-induced hemorrhage control system (jada system) complaint: consumer complained ¿broken parts¿ specifically, ¿vacuum-induced hemorrhage control system (jada system) unit was defective due to a "hole in the balloon".Inbound call from a vacuum-induced hemorrhage control system (jada system) representative (cas) reporting an ae/pqc for the vacuum-induced hemorrhage control system (jada system) on behalf of a facility.Cas reports that he was informed by a materials manager that a vacuum-induced hemorrhage control system (jada system) unit was defective due to a "hole in the balloon".Materials manager reported that the hole caused leaking when the balloon was being inflated, therefore the unit could not be used.The device is available if retrieval is desired by quality.Describe when and how the vacuum-induced hemorrhage control system (jada system) broke; balloon had a pre-existing hole which caused inflation to fail.Fluid(water) was squirting out of the hole and unit could not be used.¿ no complaint sample is available for evaluation.Reported lot # 1087342.The device will not be returned for evaluation.Without having the device to perform a visual or functional evaluation, the noted complaint cannot be confirmed.Dhr review dhr review was conducted for the top-level assembly (70-0093-001, lot 1087342) and for the subassembly part and lot number (55-0455-001, lot 1087337), and ign 3172a.Top-level device history record for lot 1087342 was reviewed: lot# 1087342 manufacturing started on 27-jun-2023.All line clearances, material verifications, and qc inspections were performed by trained spg (xeridiem) staff.Product was manufactured in accordance with the approved part specifications.There were (b)(4) scrap units during the manufacturing process.One was scrapped for lfm per tappi standard operations, and 2 were scrapped for damaged components in cell 1.Multiple inspections are conducted throughout the manufacturing process to identify defects and to ensure product integrity and quality.There were 3 ncr issued during the manufacturing of this lot.Ncr 8341-1 for missing ifu (information added from ncr 8351/ no new defect) ncr 8341 for missing ifu ncr 8350 for lfm inside tray on 10-jul-2023, there were (b)(4) devices released to specification under this lot number.Sub-level device history record for lot 1087337 was reviewed: lot# 10873-37: manufacturing started on 19-may-2023.All line clearances, material verifications, and qc inspections were performed by trained spg (xeridiem) staff.Product was manufactured in accordance with the approved part specifications.There were (b)(4) scrap units during the manufacturing process (b)(4) units were scrapped in cell three (bond bi lumen to drain tube/ pull test) (b)(4) units were scrapped for incorrect orientation between drain tube assembly and inflation valve.(b)(4) were scrapped as excess rlv at tubing connector bond site.10 were scrapped at efm> 0.4mm2 per tappi 5 were scrapped for over buffing.(b)(4) units were scrapped in cell two (connector and valve insertion/ balloon inflation check) (b)(4) units were scrapped for efm> 0.4mm2 per tappi.(b)(4) units were scrapped for balloon leak at parting line.(b)(4) units were scrapped in cell one (notching/ balloon placement.Backfill and bonding) (b)(4) units were scrapped for emf> 0.4mm2 per tappi.(b)(4) units-were-scrapped-for-no riv-backfill (b)(4) units were scrapped for over buffing.Multiple inspections are conducted throughout the manufacturing process to identify defects and to ensure product integrity and quality.There were 2 nc rs issued during the mfg of this lot.Ncr 8332 for missing curing time out batch 48.Ncr 8333 for hair in the seal on 21-jun-2023, there were (b)(4) devices released to specification under this lot number.Ign 3175a was reviewed (occlusion balloon): ign 3175a: received on 21-jun-2023 (qty 2,790).An incoming inspection was performed in accordance with the approved part specification qa21-0009).The inspection passed the entire shipment with no rejections or ncr issued.The lot was released on 15-sep-2023.On 21-jun-2023, there were 2790 devices released to specification under this lot number.The dhr review did not show any indications that would contribute to the device malfunction for deflation.All documentation and processes were followed accordingly.Provided are the manufacturing controls that are currently in place.Each unit is subject to 100% inspection per 70-0093 / 70-0093-001 pic/dhr.After assembly, the device is placed in pouches/trays, sterilized, and packaged in its final commercial configuration.The manufacturing suite is maintained to the highest standards with rules outlining clean room operating parameters (temperature, humidity, etc.), cleaning schedules for the cleanroom itself, liquid injection molding (lim) equipment, milling machines, as well as general personnel requirements for clean room usage.Once all documentation and final release testing is completed and approved, authorization for shipment is provided by organon (alydia health).This process is followed 100% with direct supervisory monitoring processes for product conformity.During the device manufacturing process, all parts are molded to the manufacturer¿s component specifications and inspected for visual defects using approved part specification drawings and pictorials (pics).The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.During assembly balloons are inflated with a specified quantity of air, submerged in 99% alcohol, and checked for leaks and bubbles along the balloon.Proper inflation is also noted during this step.Any units failing this 100% verification are discarded.Current manufacturing controls include proper training and certification of production personnel and work instructions that provide guidance for material verifications, line clearances, and quality control inspections and sampling plans are followed.Capa review: review capas opened in the last 5 years: the capa log for the previous 5 years was reviewed.Capa 588 was opened for obstructed notch on 21-oct-2022 and closed as effective on 27-apr-2023.No other capas have been issued for this defect or similar issues.Complaint records for the previous year (february 2023 - february 2024) were reviewed.For the (b)(4) device family, there are 3 documented events for device leak including this complaint.No further investigation can be conducted without having a sample to evaluate.This investigation was limited to only dhr reviews.The root cause cannot be confirmed.Since this complaint cannot be confirmed without having the device returned or additional product information for functional performance, no corrective actions are warranted.The qcc4 database shows that this is the 1st compliant occurrence (broken parts) for lot 1087342.The qcc4 database shows that this is the 9th occurrence for the vacuum-induced hemorrhage control system (jada system) attributed to category ¿broken parts¿ over the past 26 months (01-jan-2022 to 29-feb-2024).(database reflects vacuum-induced hemorrhage control system (jada system) 2 within the qcc4 system).In summary, the review by xeridiem has not highlighted any other contributing factors from the manufacturing processed that would cause the defect experienced by the customer for this event/lot.If the complaint samples become available, this complaint will be re-opened and additional investigation may be performed.Xeridiem medical devices is a division of spectrum plastics group (spg).This is an amended report to updated executive summary in narrative.
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Unit was defective due to a "hole in the balloon" [device defective].Device leakage [device leakage].'no additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a other (facility) via clinical account specialist (cas), referring to a female patient of unknown age.The patient's concurrent conditions included asthma.The patient's medical history, concomitant medications, and drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # 1087342 and expiration date were reported as 22-may-2026) via unknown route for unknown indication.Clinical account specialist reported that he was informed by a materials manager that a vacuum-induced hemorrhage control system (jada system) unit was defective due to a hole in the balloon (device defective).Materials manager reported that the hole caused leaking (device leakage) when the balloon was being inflated, therefore the unit could not be used.The vacuum-induced hemorrhage control system (jada system was available for inspection or retrieval.No additional adverse event/product quality complaint reported (no adverse event).Upon internal review, the event device defective was considered to be medically significant.Medical device reporting criteria: malfunction.Follow up information was received from other (facility) via clinical account specialist (cas) on (b)(6) 2024.The vacuum-induced hemorrhage control system (jada system) unit was not broken.Balloon had a pre-existing hole which caused inflation to fail.Fluid (water) was squirting out of the hole and unit could not be used.Operator of device was health professional.It was reported that the vacuum-induced hemorrhage control system (jada system) will not be inspected for this case and can be discarded as per protocol.
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