ASPEN SURGICAL PRODUCTS, CALEDONIA MURANAKA SURGICAL MARKING PEN W/RULER AND 6-UP LABELS, STERILE
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Model Number MMI02730PBX |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was not returned for evaluation.Photographic evidence along with the manufacturing lot number were provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the photos confirmed the issue from the distributor.Analysis of the finished good lot number was reviewed as well.According to the manufacturing process, these parts are loaded into recessed pockets on a packaging machine per specified work instructions.If incorrectly loaded or not orientated properly, the product interferes with the sealing process.This can occur during startup or troubleshooting, in which case it is the operator responsibility to review the line and clear it of any discrepancies.Therefore, the likely root cause is attributed to operator error.Production supervisors and operations were notified of this issue.Based on this information, no further action is required.
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Event Description
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Aspen surgical received a report from the distributor indicating that a surgical marking pen was found with defective seals.The item was not in use.No injury/death was reported.Customer reported multiple lots for the same issue.The lot numbers and their respective complaint numbers are as follows: (b)(4), lot 196026, (b)(4), lot 200809, (b)(4), lot 213363, (b)(4), lot 199776.
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