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 Problems
Unsealed Device Packaging (1444); Peeled/Delaminated (1454); 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 06/16/2021 |
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 return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified.(expiry date: 09/2022).
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Event Description
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It was reported that prior to the placement of power port, the outer packaging was allegedly torn.There was no patient contact.
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Event Description
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It was reported that prior to the placement of power port, the outer packaging was allegedly torn.There was no patient contact.
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Manufacturer Narrative
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H10: the initial mdr was inadvertently submitted with a g3 date of 06/18/2021.The correct g3 date is 06/16/2021.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port 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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported breach of sterile barrier as no objective evidence was provided for review.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: (expiry date: 09/2022).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: device not returned.
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Event Description
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It was reported that prior to the placement of power port, the outer packaging 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 unsealed powerport isp mri implantable port kit was returned for evaluation.The investigation is confirmed for the identified delaminated issue as the tyvek lid was noted to be delaminated into two layers.The investigation is also confirmed for the identified unsealed device packaging issue as seal transfer was noted along the lip of the tray and small layer of the outer tyvek lid was noted on the tray corner.Further during visual evaluation, the outer tyvek lid was noted to be partially peeled.However, the investigation is inconclusive for the reported torn package issue as the exact circumstances at the time of opening the package is unknown and the package was returned with partially peeled tyvek lid.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: d4 (expiry date: 09/2022), g3, h6 (device).H11: h6 (method, result).H11: section a through f ¿ the information provide by bd represents all 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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Search Alerts/Recalls
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