Catalog Number 778624 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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Event Description
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It was reported that prior to use, the device was broken.The complainant stated that the break was identified upon opening the package.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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Event Description
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It was reported that prior to use, the device was allegedly broken.The complainant stated that the break was identified upon opening the package.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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Event Description
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It was reported that prior to use, the device was allegedly broken.The complainant stated that the break was identified upon opening the package.
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Manufacturer Narrative
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Received 1 opened ureteral stent.The reported issue was confirmed; however, the cause is unknown.During the visual inspection noted that stent was broken at middle of it.The broken section presents stress mark as it was stressed beyond its tensile capacity.The stent received out of its individual sealed polybag.Per dimensional assessment the sample was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "indications for use: the bard® inlay¿ and bard® inlay¿ versafit¿ ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique." (b)(4).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.
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Event Description
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It was reported that prior to use, the device was allegedly broken.The complainant stated that the break was identified upon opening the package.
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Search Alerts/Recalls
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