Model Number D135502 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has four reports: (1) mfr # 2029046-2023-00553 for product code d135502 (celsius¿ electrophysiology catheter) (2) mfr # 2029046-2023-00554 for product code d135502 (celsius¿ electrophysiology catheter) (3) mfr # 2029046-2023-00555 for product code d135502 (celsius¿ electrophysiology catheter) (4) mfr # 2029046-2023-00556 for product code d135502 (celsius¿ electrophysiology catheter).
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Event Description
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It was reported that expired products (celsius¿ electrophysiology catheter qty 4) were received.According to the customer, expiration date label on product show (b)(6)2022.The customer received the products on (b)(6)2023.No patient was involved.The expired product shipped issue is mdr reportable to the fda.
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Manufacturer Narrative
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The investigation was completed on 20-apr-2023.It was reported that expired products (celsius¿ electrophysiology catheter qty (b)(4)) were received.According to the customer, expiration date label on product show 22-sep-2022.The customer received the products on 03-feb-2023.No patient was involved.During the investigation, it was noticed that the devices stated on this complaint were physically reworked (relabeled) at the distribution center between 25 april 2022 and 17 may 2022.The information and details should have been adjusted in the system.The four ((b)(4)) units were returned to the warehouse.No additional expired product was distributed.No other sales occurred on the products.No products were shipped from the distribution center to final customer.Finally, the devices were destroyed locally and therefore, were not returned to the product analysis lab for evaluation.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.This complaint was escalated for further investigation.H 6.Investigation conclusions code of ¿appropriate term/code not available (d17)¿ refers to the reported device not returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has four reports: (1) mfr # 2029046-2023-00553 for product code d135502 (celsius¿ electrophysiology catheter), (2) mfr # 2029046-2023-00554 for product code d135502 (celsius¿ electrophysiology catheter), (3) mfr # 2029046-2023-00555 for product code d135502 (celsius¿ electrophysiology catheter), (4) mfr # 2029046-2023-00556 for product code d135502 (celsius¿ electrophysiology catheter).
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Search Alerts/Recalls
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