C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1808000 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/14/2023 |
Event Type
Injury
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Event Description
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It was reported that sometime post port placement, the catheter was allegedly stuck and unable to be removed.It was further reported that the surgeon pulled on the catheter and stretched the catheter but was still unable to remove the catheter.Furthermore, the surgeon then trimmed the stretched catheter so he could re-attach the port body and decided to leave the whole port system in the patient.However, the port was flushed without difficulty but caused the patient experienced some pain.The current status of the patient is unknown.
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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 will 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.H10: d4 (expiration date: 04/2018).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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Search Alerts/Recalls
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