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They could not get any suction because it wasn't holding a seal because there were pinpoint holes in the device [device malfunction].Multiple small puncture holes in the cervical seal that was leaking fluid.[device physical property issue].Multiple small puncture holes in the cervical seal that was leaking fluid [poor quality device used].Case narrative: this spontaneous report originating from united states was received from a nurse manager via email referring to a female patient of unknown age.Patient's current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for unknown indication.On (b)(6) 2023, the nurse manager stated that they had a defective device, they noted multiple small puncture holes in the cervical seal that was leaking fluid ((poor quality device used) and (device physical property issue).Nurse stated it appears the staff used the device on the patient, as there was blood on the device in the picture.Nurse did not have any health care professional or patient information and did not know if the device was available for retrieval.Follow up received on 04-nov-2023.The reporter stated that vacuum pressure was not maintained.They could not get any suction because it was not holding a seal because there were pinpoint holes in the device (device malfunction).No additional information provided at this time.Upon internal review, the event of device malfunction was determined to be medically significant.Medical device reporting criteria: malfunction, serious injury.
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They could not get any suction because it wasn't holding a seal because there were pinpoint holes in the device [device malfunction].Multiple small puncture holes in the cervical seal that was leaking fluid.[device physical property issue].Multiple small puncture holes in the cervical seal that was leaking fluid [poor quality device used].Case narrative: this spontaneous report originating from united states was received from a nurse manager via email referring to a female patient of unknown age.Patient's current conditions, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for unknown indication.On (b)(6) 2023, the nurse manager stated that they had a defective device, they noted multiple small puncture holes in the cervical seal that was leaking fluid ((poor quality device used) and (device physical property issue).Nurse stated it appears the staff used the device on the patient, as there was blood on the device in the picture.Nurse did not have any health care professional or patient information and did not know if the device was available for retrieval.Follow up received on 04-nov-2023.The reporter stated that vacuum pressure was not maintained.They could not get any suction because it was not holding a seal because there were pinpoint holes in the device (device malfunction).No additional information provided at this time.Upon internal review, the event of device malfunction was determined to be medically significant.Medical device reporting criteria: malfunction, serious injury.Follow-up information was received on 17-jan-2024.An investigation into the manufacture of lot 1087321 was completed and confirmed that all in-process quality checks were satisfactory.The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures.The lot was confirmed to have met the requirements for market release.Following medical review of the ae report and the quality investigation, there were no identified concerns related to quality within the results of the investigation.Complaint description details: defective jada, multiple small puncture holes in the cervical seal that was leaking fluid.Appears used, pt blood on device.Ae-qir: device malfunction.Executive summary: jada system complaint: consumer complained of ¿broken parts¿, specifically, ¿defective jada, multiple small puncture holes in the cervical seal that was leaking fluid.Clinical educator calling to report jada system ae/pqc.Caller states she received an email from the nurse manager stating they had a defective device, they noted multiple small puncture holes in the cervical seal that was leaking fluid.Caller states it appears the staff used the device on the patient, as there is blood on the device in the picture.Reported market lot number (1087321).The sample is currently biohazardous and could not be shipped from the customer for examination.One complaint sample was available for inspection, sample evaluation was performed by organon personnel who visited the site of the event.Engineering examination: the device was clearly used with visible dried blood on the outside and blood inside the vacuum lumen and tip.The cervical seal was initially inflated with air and leaking could not be heard but the seal slowly lost volume.In order to get a sense for the leak, the air-filled seal was submerged in water.Remaining air was removed from the seal and the seal was reinflated with water.The seal was clearly leaking but the streams of water were difficult to see so they were sprayed onto the table mat for illustration.Visual observation of the holes with a magnifying glass was not possible as the holes were too small to observe.Note the location of the two holes marked with a black marker.The mark size does not reflect the size of the holes.The two holes were located on the proximal side of the seal in the balloon body and not on the sleeves.The device was discarded after the inspection.Xeridiem medical devices, the assembler of the device, was requested perform an investigation.Ign 2258a was reviewed (occlusion balloon assigned to this order): ign 2258a: received on 15-sep-2022 (qty (b)(4).An incoming inspection was performed in accordance with the approved part specification qa20-1252.The inspection passed the entire shipment with no rejections or ncr issued.The lot was released on 15-sep-2022.Dhr review was conducted for the top-level assembly (70-0093-001, lot 1087321), for the subassembly part and lot number (55-0455-001, lot 1087308), and ign 2258a.Top-level device history record for lot 1087321 was reviewed: lot# 1087321: manufacturing started on 03-nov-2022.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 12 scrap units during the manufacturing process.Six scrap was for lfm per tappi standard in cell 1 operations, and 6 were for engineering samples.Multiple inspections are conducted throughout the manufacturing process to identify defects and to ensure product integrity and quality.There were no ncr issued during the manufacturing of this lot.On 21-nov-2022, there were (b)(4) devices released to specification under this lot number.Sub-level device history record for lot 1087308 was reviewed: lot# 1087308: manufacturing started on 23-sep-2022.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 15 scrap units during the manufacturing process.Two units were scrapped for efm greater than 0.4mm2 per tappi (cell 2 operations), 9 were scrapped for balloon bubbles (holes in body of balloon) (cell 2 operations), and 4 for excessive rtv (cell 4 operations).Multiple inspections are conducted throughout the manufacturing process to identify defects and to ensure product integrity and quality.There were no ncrs issued during the mfg of this lot.On 21-nov-2022, there were (b)(4) 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.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.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.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.Complaint records for the previous year (october 2022-december 2023) were reviewed.For the 70-0093 device family and specific device, there were 2 documented complaints for pinholes (including this one).Review capas opened in the last 5 years the capa log for the previous 5 years was reviewed.No capas have been issued for this defect or similar issues.This is the only documented event under this lot number.(1087321).The qcc4 database shows that this is the 1st occurrence attributed to ¿broken parts¿ for market lot number 1087321.This complaint cannot be confirmed by xeridiem without having the device returned or additional product information; therefore, no corrective actions are warranted.In summary, the review by xeridiem have not highlighted any other contributing factors from the manufacturing processed that would cause the defect experienced by the customer.Xeridiem medical devices is a division of spectrum plastics group (spg).
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