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
Fracture (1260); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Event Description
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It was reported that fourteen days post port placement procedure via the internal jugular vein, the catheter was allegedly broken.It was further reported that the distal catheter segment and the port body were removed.There was no reported patient injury.
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Event Description
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It was reported that fourteen days post port placement procedure via the internal jugular vein, the catheter was allegedly broken.It was further reported that the distal catheter segment and the port body were removed.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 implantable port attached to a groshong catheter in two segments were returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported catheter break and separation issue as distal catheter segment was returned with its surface noted to be granular and glossy.Also, striations were noted on both complete circumferential breaks distal end of the attached catheter and on the proximal end of the distal catheter segment.Furthermore, cath-lock was not seated fully against the port body with tool damage noted on it.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 (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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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 implantable port attached to a groshong catheter in two segments were returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported catheter break and separation issue as distal catheter segment was returned with its surface noted to be granular and glossy.Also, striations were noted on both complete circumferential breaks distal end of the attached catheter and on the proximal end of the distal catheter segment.A definitive root cause could not be determined based upon the provided 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.
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Event Description
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It was reported that fourteen days post port placement procedure via the internal jugular vein, the catheter was allegedly broken.It was further reported that the distal catheter segment and the port body were removed.There was no reported patient injury.
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Search Alerts/Recalls
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