Catalog Number 38833014 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)
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Event Date 07/02/2021 |
Event Type
malfunction
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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.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the angiocath 16ga x 1.88in 1.7 x 48mm catheter was found split during the puncture.The following information was provided by the initial reporter, translated from spanish to english: "the bevel is not very sharp, the catheter blooms in most cases it is difficult to puncture, it must be done with a lot of pressure.The side effects produced by abocath angiocath are the following: increase in the number of punctures in the patient, as a good venous access is not achieved, due to what has been described in the quality failure: the catheter blooms, the sear is not very sharp.This also means that the placed via does not last long, subjecting to new punctures to place a new via and complete the indicated treatment.The same patients complain and sometimes refuse a new attempt.When the catheter blooms, it damages the veins, causing them to creep and consequently injure the affected limb (hematoma, swelling).".
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Manufacturer Narrative
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H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
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Event Description
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It was reported that the angiocath 16ga x 1.88in 1.7 x 48mm catheter was found split during the puncture.The following information was provided by the initial reporter, translated from spanish to english: "the bevel is not very sharp, the catheter blooms in most cases it is difficult to puncture, it must be done with a lot of pressure.The side effects produced by abocath angiocath are the following: increase in the number of punctures in the patient, as a good venous access is not achieved, due to what has been described in the quality failure: the catheter blooms, the sear is not very sharp.This also means that the placed via does not last long, subjecting to new punctures to place a new via and complete the indicated treatment.The same patients complain and sometimes refuse a new attempt.When the catheter blooms, it damages the veins, causing them to creep and consequently injure the affected limb (hematoma, swelling).".
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Search Alerts/Recalls
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