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Catalog Number UNK POWER HICKMAN |
Device Problems
Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
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Event Description
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It was reported that sometime post a chronic catheter placement, the catheter allegedly got worn on colored, distal plastic ends.It was further reported that the injection caps that are used on the ends of our central lines allegedly difficult to be removed from the catheter.Reportedly, clamps was used to remove the injection caps which worn down the plastic.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported difficult to remove the injection caps, wear problem and integrity issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.H3 other text : device not returned.
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Event Description
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It was reported that sometime post a chronic catheter placement, the catheter allegedly got worn on colored, distal plastic ends.It was further reported that the injection caps that are used on the ends of the central lines were allegedly difficult to be removed from the catheter.Reportedly, clamps were used to remove the injection caps which had worn down the plastic.There was no reported patient injury.
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Search Alerts/Recalls
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