C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808000 |
Device Problems
Unsealed Device Packaging (1444); 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 03/25/2021 |
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 06/2022.
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Event Description
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It was reported that during preparation for a port placement procedure, the device was allegedly found to be opened after opening the carrier box and customer fears for contamination of the device.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the device was not returned for evaluation.Therefore, the reported unsealed device packaging issue cannot be confirmed.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: 06/2022), g3, h6 (method).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.
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Event Description
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It was reported that during preparation of a port placement procedure, the device was allegedly found to be opened after opening the carrier box and customer fears for contamination of the device.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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