C.R. BARD, INC. (BASD) -3006260740 MRI POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNK MRI POWER PORT |
Device Problems
Fracture (1260); Scratched Material (3020)
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Patient Problems
Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2020 |
Event Type
Injury
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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 record will not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
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Event Description
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It was reported that post port placement, the port catheter allegedly fractured.It was further reported that the patient experienced swelling.The patient current status is unknown.
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Event Description
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It was reported that sometime post port placement, the port catheter allegedly fractured.There was no patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one mri powerport attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported port fracture issue and the identified scratched material issue, as a damage was observed on one of the suture holes on the port body and a scoring mark was noted on the cath-lock.A definitive root cause could not be determined based on the 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.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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Event Description
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It was reported that sometime post port placement, the port catheter allegedly fractured.It was further reported that the patient experienced swelling.The patient current status is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one mri powerport attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A damage was observed on one of the suture holes on the port body and a scoring mark was noted on the cath-lock.However, the findings are incidental and not related to the reported event.The investigation is unconfirmed for the reported catheter fracture issue, as no damage were observed on the catheter.The port body with attached catheter segment was patent to infusion and aspiration without issue.No leaks were observed.A definitive root cause could not be determined based upon the 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: g3, h6 (method).H11: b5, h1, h6 (patient, result and 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.
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