Model Number 000714 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2017 |
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, at this time, for evaluation.A lot history review (lhr) of ngar3319 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that patient was in use of the probe since (b)(6) 2017.On (b)(6) 2017, the probe left the stoma.Upon observing the product, the team detected cuff/balloon disruption.Water was used to inflate the balloon after placing the patient to the volume indicated in the product instructions.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 a damaged feeding tube balloon bolster was confirmed and the cause appears to be use related.The product returned for evaluation was a 14fr tri-funnel feeding tube.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through over-filling the feeding tube balloon.The appropriate inflation volume is listed on the inflation valve and over-inflation can be avoided by fully draining the balloon prior to inflation.The returned product sample was evaluated and a longitudinally-aligned split in the balloon membrane was observed near the proximal end of the balloon.This catheter damage was determined to be typical of a burst, and the characteristics observed which supported this type of failure included: tensile weakness in the membrane at the fracture site (due to over-inflation prior to burst).Granular fracture surface texture (typical of tearing failure modes).The split in the balloon was longitudinally aligned which is typical of burst-type failures.Additionally, residual material and discoloration was seen throughout the sample which established a usage history of the product and suggested the product had worked as intended for a period of time prior to the event.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.These features are characteristically found due to the over-inflation and fracture of the balloon tubing.The product instruction for use (ifu) contains the following information which may be relevant to this type of event, "do not exceed the maximum recommended inflation volume as this may cause excessive pressure on the gastric mucosa and migration of the internal balloon into the peritoneal cavity".
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Event Description
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It was reported that patient was in use of the probe since (b)(6) 2017.On (b)(6) 2017, the probe left the stoma.Upon observing the product, the team detected cuff/balloon disruption.Water was used to inflate the balloon after placing the patient to the volume indicated in the product instructions.No patient injury was reported.
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Search Alerts/Recalls
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