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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Catalog Number 9808560 |
Device Problems
Fracture (1260); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: 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.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 pending return.
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Event Description
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It was reported that two years, eleven months and twelve days post a port placement using internal cervical approach, the catheter was allegedly found to be damaged.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Small splits were noted on the proximal end of the attached catheter.A partial compound break was noted approximately 6.0cm from the distal end of the cath-lock.The edges of the partial circumferential break on the attached catheter were noted to be uneven.The surface was noted to be round and smooth on both regions.Therefore, the investigation is confirmed for the reported catheter damage and identified fracture issue as the more specific damage such as splits were noted on the sample.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 : see h10.
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Event Description
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It was reported that two years, eleven months and twelve days post a port placement using internal cervical approach, the catheter was allegedly found to be damaged upon removal.There was no reported patient injury.
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Search Alerts/Recalls
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