C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0606150J |
Device Problems
Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified.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: 12/2020).
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Event Description
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It was reported that some time post a port placement, a crack was allegedly found on the catheter.It was further reported that catheter allegedly kinked.The distal catheter segment was removed.The there was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received and the file was reassessed for reportability and determined to be reportable as a serious injury.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, groshong single-lumen, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bard ti implantable port attached to a groshong catheter in two segments were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture, material separation, deformation and the identified wear issues, as a complete compound break was noted on the distal end of the catheter attached.A complete compound break was noted on the proximal end of the distal catheter segment.A partial c-shaped break was noted approximately 0.7cm from the proximal end of the distal catheter segment.The surface of the complete compound break on the distal end of the catheter attached was noted to be round in one region and granular in the other region.The surface of the complete compound break on the proximal end of the distal catheter segment was noted to be round in one region and granular in the other region.The surface of the partial c-shaped break on the distal catheter segment were noted to be round in two regions.Although sample was returned for evaluation, two medical images were provided for review.The investigation is confirmed for the identified migration issue, as the catheter appears to have migrated more proximally above the clavicle based on the provided images.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The definitive root cause could not be determined based upon 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 some time post a port placement, a crack was allegedly found on the catheter.It was further reported that the catheter allegedly kinked.The kinked part of the catheter was broken during the catheter removal, and the distal catheter segment was removed.Reportedly, catheter allegedly migrated.The current status of the patient is unknown.
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Search Alerts/Recalls
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