C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 9808560 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the text on pages 1, 4, 13, and 16 of the patient's guide was printed twice.There was no reported 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 records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 04/2024).
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Event Description
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It was reported that the text on pages 1, 4, 13, and 16 of the patient's guide was printed twice.There was no reported patient involvement.
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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 sample was not returned for evaluation.Five electronic photos were provided for review.The investigation is confirmed for the reported illegible information issue as the text shown in all the five photos of the implanted guide was noted to be printed twice and not clear enough to read the provided content in the patient guide.A definitive root cause for the could not be determined based upon the provided 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.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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