Model Number 400273 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the kit perisafe 18ga 3-1/2in weiss experienced the catheter breaking apart.An x-ray was administered to the patient in an attempt to locate a broken piece of the device believed to be embedded within the patient.The following information was provided by the initial reporter: catheter broken while reinserting in the patient.The dr at the hospital was using perisafe on the patient, they tried to reinsert in 2nd attempt while reinserting they noticed that 2-3 cm of catheter was broken and tried to locate the broken part.They tried to locate by taking x-ray, ct of lumbar region and ultrasound but could not locate the same.However they confirmed the patient is doing fine as of now.They completed the procedure by using another unit.
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Manufacturer Narrative
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The following fields were updated due to additional information: d4: medical device lot #: 8115818.D4: medical device expiration date: 5/31/2023.H4: device manufacture date: 6/1/2018.D9: device available for eval?: yes.D9: returned to manufacturer on: 9/21/2021.H6: investigation: based on the sample provided to bd for evaluation, the reported condition was verified.It was observed under magnification that the tip of the catheter was broken (torn) at an angle similar to a bevel cut (not a straight cut).In addition, five to six consecutive scratches can be observed near the broken tip.The scratches are on the outside of the tube and are located only on the top side.Scratches do not go around the tube.The only scratches seen throughout the catheter are the ones identified on the tip next to the torn part (tip).A review of the device history record was performed, and no quality issues were found during production.Upon further assessment, it was noted that shearing of an epidural catheter could occur if the catheter was placed throughout the needle or withdrawn, and during the procedure, the catheter could have bent.The act of withdrawing or pulling the catheter could result in the catheter becoming sheared.
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Event Description
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It was reported that the kit perisafe 18ga 3-1/2in weiss experienced the catheter breaking apart.An x-ray was administered to the patient in an attempt to locate a broken piece of the device believed to be embedded within the patient.The following information was provided by the initial reporter: catheter broken while reinserting in the patient.The dr at the hospital was using perisafe on the patient, they tried to reinsert in 2nd attempt while reinserting they noticed that 2-3 cm of catheter was broken and tried to locate the broken part.They tried to locate by taking x-ray, ct of lumbar region and ultrasound but could not locate the same.However they confirmed the patient is doing fine as of now.They completed the procedure by using another unit.
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Search Alerts/Recalls
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