Model Number 0603880 |
Device Problems
Defective Component (2292); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
Vascular Dissection (3160)
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Event Date 09/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will 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.(expiration date: 05/2023).
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Event Description
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It was reported that during port device implant procedure, the dilator was allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
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Event Description
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It was reported that during port device implant procedure, the dilator was allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
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Manufacturer Narrative
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H10: manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However, 3 photographs were returned for evaluation the investigation is confirmed for introducer damage as one of the photos shows apparent deformation on the tips of the sheath and the dilator.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 05/2023); g4 h11: h6 (resultsand conclusion) 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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Manufacturer Narrative
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H10: manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: one sheath/dilator was returned for evaluation.Gross examination showed the element to have been effectively used in that the vessel dilator showed multiple multi aspect curves and the distal end evidence of distortion damage with splits.Detailed examination of the peel apart sheath showed a rumpled crease mark just distal to the peel apart handles, just proximal to the distal end, and a length peeled back segment at the distal end of the sheath.The tip of the introducer sheath, when split, was found to manifest some evidence of the tipping manufacturing process, which tapers the sheath tip.In addition, 3 photographs were returned for evaluation the photo evaluation confirms introducer damage as one of the photos shows apparent deformation on the tips of the sheath and the dilator.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 05/2023); g4 h11: b5, h2, h3, h6 (device code, method and results).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 during port implant, the dilator allegedly damaged while dilating over the guidewire.Therefore, the dilator could not be used to complete the procedure.Reportedly, dissection through the skin and subcutaneous tissue was performed.The patient was reported as stable.
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Search Alerts/Recalls
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