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Model Number HEWROOT0030 |
Device Problems
Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the event date was set on (b)(6) 2021 as it was the day the damage was found.However, the parcel was in transit from (b)(6) 2021, therefore the event might have occurred between these two dates.It was reported that the product is available for investigation, it should be returned to intervascular for examination in the coming days.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20m03.Trend performed on damaged packaging events for intergard products (which include cardioroot) showed since last 12 months an occurrence still in accordance with the maximum anticipated occurrence rate set in the product risk management file.According to the r&d department: the shipping boxes have been validated during transport tests according to ista or astmd4169 standard.The validation aimed to demonstrate the maintenance of the sterile barrier integrity in accordance with the iso11607-1 standard.Integrity was compliant during validations.Regarding the finger perforation test, it could be close to a concentrated impact test.As the involved shipping boxes are double grooved cardboard, the "concentrated impact" test is not applicable according to the astm standard.There is therefore no incompatibility between having validated shipping boxes and the fact that when applying localized pressure, there may be deterioration of the outer packaging.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
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Event Description
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(b)(4).Upon delivery to the customer (distributor), product arrived in a damaged shipping box.According to the customer, the shipping cardboard had holes that unfortunately damaged the box of one of the two cardioroot products delivered in the same shipping box, no longer guaranteeing the sterility of the product and preventing the distributor from delivering it to end customers.The deliveryman told that the white boxes (shipping boxes) are not the most robust.According to him, they dig with a simple push of the thumb.The customer refused the whole delivery and could not tell which one of the two products is damaged.Therefore, another mdr is associated with the same event (complaint #(b)(4)).
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Event Description
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See initial mfr report 1640201-2021-00003.Complaint #(b)(4).
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Manufacturer Narrative
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Corrected data: in h6, following device evaluation, device code set as 1421 in the initial mdr is replaced by 1570.Additional manufacturer narrative: (10/213) the shipping cardboard with the two cardioroot products was received at intervascular and was inspected by the quality assurance manager for evaluation.It was concluded that the product serial number (b)(6) (complaint #(b)(4)) has no defect, it is compliant.(67) although the shipping box was damaged during transport, the product serial number (b)(6) inside remained intact.Therefore, the device problem was not confirmed for this case.
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Search Alerts/Recalls
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