C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806060 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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: 08/2023.
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Event Description
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It was reported that prior to a port placement procedure, the packaging of the device was allegedly torn.There was no patient contact.
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Manufacturer Narrative
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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 mri isp implantable port kit in its unsealed original package was returned for evaluation.Gross visual evaluation was performed.During visual evaluation top tyvek label appeared to be partially teared from the tyvek tray on the upper right corner and seal transfer was noted along the right border of the tray.Manufacturing site evaluation of the sample found a trace of adhesive tape on the packing box and a translucent stain was observed on the lidstock of the outer tray that appeared to be a burn possibly caused during the tray sealing process.Also the unit label was slightly peeled off at the top right of the lidstock, possibly due to a lack of adhesion.It was observed that the lidstock was torn in the area of the tray sealing, a section of the lidstock had been properly detached and a part remained adhered to the tray in the sealing section.Therefore the investigation is confirmed for the reported packaging of the device torn issue.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: 08/2023).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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Event Description
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It was reported that prior to a port placement procedure, the packaging of the device was allegedly torn.There was no patient contact.
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Search Alerts/Recalls
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