BARD ACCESS SYSTEMS DOT STC PPICC MAX, SOLO 5 FR TL, FULL W/TCS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
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Model Number 1395108QD |
Device Problems
Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Malposition of Device (2616)
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Patient Problem
Blood Loss (2597)
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Event Date 06/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.
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Event Description
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It was reported by the facility, via the sales rep, that the bedside nurse reported an occluded picc to the picc team.The picc nurse assessed the right basilic picc, changed injection caps, and flushed.The picc nurse was able to flush all three lumens, but only got intermittent blood return from two of the three lumens (red and gray).She suspected the picc had malposition to the right ij, but the patient was very agitated so chest x-ray was delayed.The bedside nurse called again twenty minutes later saying that there was blood drainage at the insertion site.The x-ray had been completed then and showed the tip in the lower svc to acj.On assessing the site the second time, she noted a saturated guardiva patch.Under the dressing there was blood and "milky" drainage.The patient was on a propfol drip for sedation, which is a milky white.This caused the nurse to suspect catheter damage.She started a peripheral iv and gave propfol through it and the patient immediately calmed.She removed the picc line and was able to clearly see a rupture at the 5 cm marking.There was a small amount of swelling to his upper arm, but his medications were low volume.A picc had to be placed in the patient's left arm.No patient injury was reported.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an occluded and damaged catheter was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr t/l powerpicc solo catheter.The sample contained red usage residue throughout and two parallel splits in the catheter were found at the 5cm depth marking.The splits were adjacent to each other and were the same length.Further examination showed that each split was associated with either small lumen of the catheter.Additionally, a region of catheter was found at the 14cm depth marking which was ballooned in nature.Functional testing showed that the catheter was occluded through both small lumens immediately distal to both splits.Additionally, the catheter was found to be occluded immediately distal to the ballooned region of catheter.Microscopic examination of the catheter splits showed that the fracture surfaces were dull and granular in nature and that the catheter material had been stretched on either side of both splits.The observed damage was characteristic of catheter over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The observed occlusions were found to be related to infusate buildup and were likely associated with the bursts due to the location of the bursts.An examination of the catheter revealed no potential damage/defect related to manufacture of the product.
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Event Description
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It was reported by the facility, via the sales rep, that the bedside nurse reported an occluded picc to the picc team.The picc nurse assessed the right basilic picc, changed injection caps, and flushed.The picc nurse was able to flush all three lumens, but only got intermittent blood return from two of the three lumens (red and gray).She suspected the picc had malposition to the right ij, but the patient was very agitated so chest x-ray was delayed.The bedside nurse called again twenty minutes later saying that there was blood drainage at the insertion site.The x-ray had been completed then and showed the tip in the lower svc to acj.On assessing the site the second time, she noted a saturated guardiva patch.Under the dressing there was blood and "milky" drainage.The patient was on a propfol drip for sedation, which is a milky white.This caused the nurse to suspect catheter damage.She started a peripheral iv and gave propfol through it and the patient immediately calmed.She removed the picc line and was able to clearly see a rupture at the 5 cm marking.There was a small amount of swelling to his upper arm, but his medications were low volume.A picc had to be placed in the patient's left arm.No patient injury was reported.
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