C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 9808560 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Ambient Temperature Problem (2878); 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 10/16/2020 |
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: 12/2022).
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Event Description
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It was reported that prior to a procedure, the adhesive on the inner tray was allegedly hardened.It was further reported that the inner tray allegedly broke upon opening it.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the tenth complaint reported for this product/lot number combination.A device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri isp kit was returned for evaluation.Visual evaluation was performed on the returned kit.The investigation is confirmed for the reported packaging problem, specifically for an ambient temperature problem, as the packaging tray was found to be warped.Although the packaging tray was found cracked and broken with two pieces of the plastic tray broken completely, the exact circumstances at the time of opening the package are unknown; the complaint comments report that the inner tray cracked upon opening the packaging.Based upon the available information 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.H10: d4 (expiry date: 12/2022).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.H3 other text : see h10.
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Event Description
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It was reported that prior to a procedure, the adhesive on the inner tray was allegedly hardened.It was further reported that the inner tray allegedly broke upon opening it.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the tenth complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: one powerport mri isp kit was returned for evaluation.Visual evaluation was performed on the returned kit.The investigation is confirmed for the reported packaging problem, hole in packaging, specifically for an ambient temperature problem, as the packaging tray was found to be warped.The investigation is inconclusive for material bent/twist although the packaging tray was found cracked and broken with two pieces of the plastic tray broken completely, the exact circumstances at the time of opening the package are unknown; the complaint comments report that the inner tray cracked upon opening the packaging.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: 12/2022).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 prior to port placement procedure, the adhesive on the inner tray was allegedly hardened.It was further reported that the inner tray allegedly broke upon opening it.There was no patient contact.
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Search Alerts/Recalls
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