C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1616000 |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2022 |
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 record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
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Event Description
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It was reported that upon scanning the barcode of the device, the scanned product allegedly displays a different reference number instead of the original reference number.There was no patient involvement.
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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 record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
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Event Description
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It was reported that upon scanning the barcode of the device, the scanned product allegedly displays a different reference number instead of the original reference number.There was no patient involvement.
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Event Description
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It was reported that prior to a port placement procedure, the product allegedly displays a different reference number instead of the original reference number while scanning the barcode.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: the physical sample was not returned for evaluation, one electronic photo was provided for review.The photo shows a product packaging label of a powerport clearvue slim implantable port.The label indicates product catalog number 1616000, lot number refx4030 and expiration date 2023-03-31.A bar code on the bottom of the label was noted to be highlighted by the user.However, the provided photo is not sufficient enough to confirm the reported event.Therefore, the investigation is inconclusive for the reported inaccurate information.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: 03/2023).
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