C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 9.6F; CHRONIC CATHETERS
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Model Number 0601630 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2021 |
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.
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Event Description
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It was reported that prior to a procedure, the kit does not include a silicone adhesive.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported component missing issue.A definitive root cause could not be determined.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.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 prior to a procedure, the kit does not include a silicone adhesive.There was no patient contact.
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Search Alerts/Recalls
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