C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8 FR GROSHONG, INT WO SP, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8808561 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: 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.However, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2025).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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Event Description
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It was reported that during preparation of a port placement procedure procedure, the packaging inside was not sticky and allegedly not sealed when opening the product box.The procedure was completed by using another device.There was no patient contact.
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Search Alerts/Recalls
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