| Model Number 400273 |
| Device Problem
Leak/Splash (1354)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 10/21/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: one photo was received by our quality team for evaluation.The photo was of a filter 2334200aau (filter flat epidural) with an arrow in which pointed out where the leak occurred; however, the leak was not observed.The incident could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, a root cause could not be determined since the incident could not be verified.Epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.This incident has been added to our database of reported incidents.Investigation conclusion: not confirmed, bd juncos was not able to confirm the customer indicated failure with picture share as evidence.Epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.Root cause description: not determined.The root cause cannot be associated with the manufacturing process since no indications from the manufacturing records review of situations that could contribute to the customer reported failure.The filter comply with inspections requirement and were found in accordance with bd specifications.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
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Event Description
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It was reported that the bd perisafe¿ epidural mini-kit filter leaked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when puncturing and after connecting the filter, it appears that the filter is leaking.Not there height of the connectors, but there is in the middle of the side, droplet formation is seen (exactly as if there is a hole in the side of the disc or it leaks at the side of the disc).".
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Manufacturer Narrative
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Corrections: samples have been received and the investigation has been updated.The following fields have been corrected: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 2020-12-04 investigation: h.6.Investigation summary: one photo and a closed perisafe kit material 400273 lot 9326023 and one loose filter material (what appears to be filter with leak) was received by our quality team for evaluation.Evaluation of the filters was done in which visual inspection under 10x magnification was done and both filters met visual requirements.On the filter send (the loose one) it was observed that customer make some markings in which point out where the leak occurred (same as the picture send).A leak test for reference only was done.The filter received (complaint actual sample) failed leak reference test and it leaked in the side of the filter.The other filter (representative sample) passed leak test.Based on this inspection it can be verified the leak condition for one of the two samples received.However, sample that fail reference leak test, was used by customer and cannot be point out if leak defected was prior or after usage of customer (one time use component).A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Although product specification recommends that epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.Supplier test filter for liquid flow rate under 45psi.Impacted filter lots pass supplier liquid flow rate test and filter comply with inspections requirement and were found in accordance with bd specifications.This investigation consisted in the evaluation of the incoming inspection records of the epidural filter component (material no.2334200aau) which was reported to leak by the customer.In addition, a review of the needle assembly and packaging process will be conducted for any indication of situations that could contribute to the customer reported failure.The perisafe technical file atf0009 was used as reference document on this investigation.The production of kits is essentially a packaging operation which consists of placing components into the preformed blister, placing a lid onto the blister, sealing the package, and finally dies cutting the package away from the trim.Finished assemblies are inspected as appropriate.According to product specification, sp1848, the perisafe epidural anesthesia mini-kit provide the basic components necessary to perform the epidural anesthesia procedure.In this procedure the epidural needle is positioned first, then filter and catheter is positioned to provide continuous epidural anesthesia.Epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.The device comprises the following components: fixed wing epidural needle / material no.5002059aau nylon epidural catheter pack / material no.4829500aau c epidural filter assembly / material no.5002056aau (assembly the filter flat epidural 2334200aau & cap male 8304741) lor syringe / material no.405199 catheter connector / material no.4882200aau preformed blister / material no.3040700aa tyvek lid / material no.8605980 from these components, the filter requirement is based sb855 product specification.All these components listed in sp1848, are received from different bd juncos approved suppliers (internal/external) and are subjected to the applicable receiving inspection at the incoming area.Then, components are dispatched to the alloyd packaging line according to the catalog production schedule.The only component from this kit that is assembled in bd juncos manufacturing process is the fixed wing epidural needle.The remaining components are only processed in the packaging area where the perisafe kit is prepared.Incoming inspection: the component involved in the complaint is the epidural filter 2334200aau lots 12934290 and 3331254.This component is supplied by external supplier which test the filter for flow rate and pressure test as per sb855.These lots were released on 30aug2017 and 10oct2018 with acceptable results.Needle assembly process: the needle 18ga x 3 ½in fixed wing was assembled under part number 5002059aau lot 93230064 in the auburg insert molding machine and no non-conformances reported from the needle assembly process.Machine conditions: no breakdowns were reported on auburg insert molded and alloyd packing machines during the period when the lot was processed.Preventive maintenance on the auburg and alloyd machines were conducted as per schedule.Review of instrument calibrations identified in quality inspection records was conducted and they were calibrated within their calibration due dates.Perisafe packaging process: on the packaging area the filter is assemble with cap male and is manually placed in the tray to be sealed in the alloyd packaging machine.No indications on the mini kit process fmea, rm692 of failures associated with filter leakage.The only potential failures at fmea for the assemble the filter and the cap is incorrect assembly or contamination that is categorized with a higher severity of s2.The current controls in the fmea is the incoming inspections and for other failures in the packaging process such as missing components or incorrect components are the 100% visual inspection at next step operation and incoming inspection.The perisafe lot 9326023 was released in quarantine for sterilization process on18dec2019.A total of 6,260 units were released from sterilization on 07jan2020.The lot expiration date is 30nov2024.Investigation conclusion: confirmed: bd juncos was able to confirm the leak condition for one of the two samples received.However, sample that fail reference leak test, was used by customer and cannot be point out if leak defect was prior of after usage of customer (one time use component).Although product specification recommend that epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.Supplier test filter for liquid flow rate under 45psi.Impacted filter lots pass supplier liquid flow rate test and filter comply with inspections requirement and were found in accordance with bd specifications.Root cause description: damage filter.The root cause can be associated with supplier assembly process.Quality alert notification was send to supplier to communicate the complaint.Not confirmed, bd juncos was not able to confirm the customer indicated failure with picture share as evidence.Epidural catheter connector, catheter, and optional filter assembly together shall not leak when liquid is forced through at 15 psi.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.A quality alert will be share with supplier to communicate the complaint.See section h.10.
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Event Description
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It was reported that the bd perisafe¿ epidural mini-kit filter leaked during use.The following information was provided by the initial reporter, translated from dutch to english: "when puncturing and after connecting the filter, it appears that the filter is leaking.Not there height of the connectors, but there is in the middle of the side, droplet formation is seen (exactly as if there is a hole in the side of the disc or it leaks at the side of the disc).".
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Search Alerts/Recalls
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