Model Number DR4054 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2024).
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Event Description
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It was reported that during preparation for an angioplasty procedure, the catheter shaft was allegedly found to be rough approximately five cm from the tip.The procedure was completed by using another device.There was no patient contact.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 01/2024), g3.H11: section a through f: the information provide 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 preparation for an angioplasty procedure, the catheter shaft was allegedly found to be rough approximately five cm from the tip.The procedure was completed by using another device.There was no patient contact.
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Search Alerts/Recalls
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