| Catalog Number D135502 |
| Device Problem
Expiration Date Error (2528)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 07/15/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30071387m number, and no internal action related to the reported complaint condition were identified.Manufacturer's ref.# (b)(4).
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Event Description
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A customer reported receiving two expired celsius¿ electrophysiology catheters and the lot number on the devices was different from the lot number on the invoice.The lot # on the invoice was reported as 30183003m with the lot # on the device packaging as 30071387m.No patient consequences were reported.On 7/29/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the device was never used.It was found in the sealed original pouches.The lot # 30071387m was received and beyond the expiration date.These findings were consistent with the customer¿s reported issue.The reported issue of expired product being shipped as been assessed as an mdr reportable malfunction.The customer reported two devices were affected, therefore, biosense webster manufacturer's reference number (b)(4) has two mdrs for the reported event: mfr # 2029046-2019-03534 for product code d135502 (celsius¿ electrophysiology catheters).Mfr # 2029046-2019-03535 for product code d135502 (celsius¿ electrophysiology catheters).
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Manufacturer Narrative
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On (b)(6)2019 it was noticed that the the date referenced in fields b5.Event description and d10.Date device returned to manufacturer was inadvertently reported as(b)(6)2019 , however, the correct date is(b)(6)2019.Manufacturer's ref # (b)(4).
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Manufacturer Narrative
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On (b)(6)2019 , biosense webster inc.Received additional information indicating the date of event was actually 7/15/2019 and not 7/1/2019.Field b3.Date of event has been populated accordingly.It was also reported that the issue of the expired catheter was discovered by the receiving staff at the storage facility.The product never arrived to the cath lab.Manufacturer¿s ref # (b)(4).
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Manufacturer Narrative
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A customer reported receiving two expired celsius¿ electrophysiology catheters and the lot number on the devices was different from the lot number on the invoice.The lot # on the invoice was reported as 30183003m with the lot # on the device packaging as 30071387m.No patient consequences were reported.On 7/26/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the device was never used.It was found in the sealed original pouches.The lot # 30071387m was received and beyond the expiration date.These findings were consistent with the customer¿s reported issue.On 12/23/2019, biosense webster inc.Received additional information indicating that the issue of the expired catheter was discovered by the receiving staff at the storage facility.The product never arrived to the cath lab.The product investigation details: the product investigation has been completed.It was reported by johnson & johnson health care systems (jjhcs) that the incorrect lot number for the catheter was shipped to the account.The lot number was different from the lot number on the invoice for order number 117578900.Caller jjhcs also reported that the catheter lot number was expired upon receipt.Caller is requesting a replacement catheter.Caller did not have any other information available, and the availability of the catheter is unknown.1.The shipping history for this account for lot 30183003m and 30071387m was reviewed.A.From lot 30183003m the account received two units, 1 in 04/29/2019 and 1 in 07/15/2019 with expiration date 02/02/2020.B.From lot 30071387m the account received five devices with expiration date of 06/07/2019; on each of the following dates: 01/21/2019 ¿ 1 unit; 01/30/2019 ¿ 1 unit; 03/07/2019 ¿ 1 unit; 03/08/2019 ¿ 2 units.2.Shipping history of each lot were reviewed.A.The shipping history of lot 30183003m was reviewed; all the 20 units released on this lot were shipped to 5 different accounts including redmond regl medcl ctr.B.The shipping history of lot 30071387m was reviewed; 12 units out of 24 in the order were distributed within 4 different accounts including redmond regl medcl ctr.Objective evidence demonstrates the remaining 12 units were removed from inventory on 06/21/2019 at the distribution center and sent for destruction to a different site; therefore, units of the lot 30071387m were no longer available on july/15.Internal procedure to destroy expired and near to expire units, include activities as inspecting each individual unit lot.Customer complaint cannot be confirmed as the objective evidence demonstrates the account received units from both lot numbers (30183003m and 30071387m) and the receipt dates at the hospital were before the expiration date of each lot.Furthermore, the shipping history of each lot demonstrates each unit was shipped to either an account or to the destruction site prior to the expiration date.Lastly, the shipping history shows the lot shipped on 07/15/2019 to redmond regl medcl ctr was lot 30183003m.The reported complaint could be related to the mishandling of the units at the account, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30071387m number, and no internal actions related to the reported complaint condition were identified.Manufacturer¿s ref # (b)(4).
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Search Alerts/Recalls
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