C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1716070J |
Device Problems
Illegible Information (4050); Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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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 powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is 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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).
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Event Description
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It was reported that prior to a port placement procedure, the depth markings allegedly not printed on the catheter.The procedure was completed using another device.There was no patient contact.
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Event Description
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It was reported that prior to a port placement procedure, the depth markings allegedly not printed on the catheter.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport slim implantable port and a catheter were returned for evaluation and two electronic photos were provided for review.Gross visual evaluation was performed on the returned device.The investigation is confirmed for the reported missing depth markings on the catheter issue as no depth marks were noted throughout the catheter was also observed on the provided photos.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.H10: d4 (expiry date: 04/2023).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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Search Alerts/Recalls
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