C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 5608062 |
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 04/21/2022 |
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 as well as a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).
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Event Description
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It was reported that during preparation of a port placement procedure, the sterility was allegedly lost.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 sealed powerport clearvue isp implantable port kit was returned for evaluation.Gross visual evaluation was performed on the returned device.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported tear, rip or hole in device packaging issue, as a hole was noted on the external lid and tyvek lid of the device packaging.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: 06/2023).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.H3 other text : see h10.
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Event Description
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It was reported that during preparation of a port placement procedure, the sterility was allegedly lost.There was no patient contact.
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Search Alerts/Recalls
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