Model Number 382269 |
Device Problems
Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 during use the angiocath special orn 14 ga x 5.25 in needle broke/detached, catheter broke, separated from hub.Medical attention required.The following information was provided by the initial reporter: the needles have been bending or breaking during mr ablation radiology procedures.While utilizing the catheter as an introducer for cryoneedle placement in both situations and on removal the catheter fractured.This catheter has been used in this manner for 11 years without prior incident.In both cases the catheter fractured in the subcutaneous tissues necessitating a small incision with image guided catheter extraction.In both cases no significant injury resulted to the patient and no catheter parts were left in the patient.".
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Event Description
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It was reported during use the angiocath special orn 14ga x 5.25in needle broke/detached, catheter broke, separated from hub.Medical attention required.The following information was provided by the initial reporter: the needles have been bending or breaking during mr ablation radiology procedures.While utilizing the catheter as an introducer for cryoneedle placement in both situations and on removal the catheter fractured.This catheter has been used in this manner for 11 years without prior incident.In both cases the catheter fractured in the subcutaneous tissues necessitating a small incision with image guided catheter extraction.In both cases no significant injury resulted to the patient and no catheter parts were left in the patient.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-14 h.6.Investigation summary : one used sample was returned for evaluation by our quality engineer team.At this time, our manufacturing facility is not handling used samples due to covid-19 concerns; therefore, an investigation was completed by referencing a picture of the sample.A thorough investigation utilizing other methodologies and available information was completed to the best of our ability.As a lot number was unknown for this incident, a review of the production history could not be completed.Through examination of the picture, the catheter was observed bent.Our manufacturing team inspected the production process for a potential source of this defect; however, nothing abnormal was detected.Considering the magnitude of the catheter bend, it has been determined that this defect would have been detected if it occurred during assembly or packaging, due to the 100% inspection process.A manufacturing related cause could not be identified for this incident.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.H3 other text : see h.10.
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Search Alerts/Recalls
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