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Model Number 5833690 |
Device Problems
Difficult to Insert (1316); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Twisted/Bent (2981); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records was 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.H10: d4 (expiration date: 03/2024).H11: section a through f ¿ the information provided by bd represents all 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 a dialysis catheter placement procedure, catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2024).H11: section a through f ¿ the information provided by bd represents all 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 during a dialysis catheter placement procedure, catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a dialysis catheter placement procedure via subclavian vein, the catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.It was also reported that the product packaging allegedly had deformation.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm hemostar d/l catheter kit.Following components were received: one 19cm hemostar d/l catheter, one 8fr dilator, one 12fr dilator, one 15fr peel-apart sheath and vessel dilator, one j-tip guidewire in a guidewire hoop, one tunneler, one introducer needle and two end caps.Gross visual, tactile and functional evaluations were performed.The 19cm hemostar d/l catheter was noted to be bent.An attempt to load the catheter to the received guidewire was performed and was successful.Therefore the investigation is confirmed for the reported catheter deformation issues.However the investigation is unconfirmed for the reported failure to advance issue as the catheter was observed sliding along the wire with no issue.The investigation is inconclusive for the reported packaging problem issue as there was no objective evidence provided.The definitive 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: 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.
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Search Alerts/Recalls
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