C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1616070 |
Device Problems
Separation Failure (2547); Deformation Due to Compressive Stress (2889); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2021 |
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 return of the sample is pending.The investigation of the reported event is currently underway.
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Event Description
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It was reported that during a procedure, the sheath allegedly could not be peeled off.There was no reported patient injury.
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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 record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2021).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 a procedure, the sheath allegedly could not be peeled off.There was no reported patient injury.
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Event Description
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It was reported that during a procedure, the sheath allegedly could not be peeled off.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: one peel-apart sheath were returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified deformation issue as multiple kinks were noted just distal to the handle on the peel-apart sheath which was returned peeled apart.The investigation is also confirmed for the reported difficult or delayed separation and identified separation failure as the valve of the peel-apart sheath did not appear be broken.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: 10/2021), g3, h6 (device, method).H11: h6 (result, 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.H3 other text : see h10.
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Search Alerts/Recalls
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