C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/12/2024 |
Event Type
Injury
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Event Description
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It was reported that there was an incident with a powerglide pro rt.The nurse broke the midline off in a patient¿s arm.Stated that she may have sheared the catheter when she told them she advanced the guidewire and then advanced the catheter and hit resistance halfway, so she then pulled the wings back and tried to re-advance and then couldn¿t remove the device.When she was able to pull back on the device with some manipulation and half the catheter came out.The other half of the catheter was in the patient¿s arm.Doctor was called and was able to come and remove the device at bedside.Stated the extra catheter was not in the vein and was in tissue.Customer states that they educated her on why this happened and not re-advancing the catheter.Patient had to have the catheter removed from arm.Additional information received 02/15/2024: it was reported no patient injury.Event resulted in a delay or change of treatment.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported that there was an incident with a powerglide pro rt.The nurse broke the midline off in a patient¿s arm.Stated that she may have sheared the catheter when she told them she advanced the guidewire and then advanced the catheter and hit resistance halfway, so she then pulled the wings back and tried to re-advance and then couldn¿t remove the device.When she was able to pull back on the device with some manipulation and half the catheter came out.The other half of the catheter was in the patient¿s arm.Doctor was called and was able to come and remove the device at bedside.Stated the extra catheter was not in the vein and was in tissue.Customer states that they educated her on why this happened and not re-advancing the catheter.Patient had to have the catheter removed from arm.Additional information received 02/15/2024: it was reported no patient injury.Event resulted in a delay or change of treatment.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a break in the catheter is confirmed and was determined to be use related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation showed abundant blood use residues throughout the returned powerglide pro.The safety mechanism was advanced over the tip of the needle.The guidewire was advanced out of the distal end of the needle tip.The distal tip of the guidewire appeared bent.The returned catheter was returned detached from the powerglide pro.The returned catheter was observed to be circumferentially broken about halfway down the catheter shaft.A microscopic observation revealed a chevron-shaped break in the catheter.The catheter fracture surface appeared granular and uneven.Because of the observed characteristics of the break site in the catheter and the advancement into the tissue of the patient described in the event description, the complaint of a broken catheter is confirmed and was determined to be use related and appeared to be caused by contact between the catheter and the introducer needle tip.This complaint will be recorded for future trending and monitoring purposes.
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