BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SPINAL¿NEEDLE; NEEDLE, CONDUCTION, ANESTETIC
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Catalog Number 408380 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that 3 bd spinal¿needle had the packaging tear while opening leaving paper shards in the sterile field.The following information was provided by the initial reporter: " it has been identified that when opening the package it tears, and doesn't open according to sterile way, leading to risk of contamination to product.".
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Manufacturer Narrative
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Initial reporter fax number: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to corrected information: b.5.Describe event or problem: it was reported that 4 bd spinal¿needle had the packaging tear while opening leaving paper shards in the sterile field.The following information was provided by the initial reporter: " it has been identified that when opening the package it tears, and doesn't open according to sterile way, leading to risk of contamination to product." h.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0027609, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the package was torn.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.
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Event Description
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It was reported that 4 bd spinal¿needle had the packaging tear while opening leaving paper shards in the sterile field.The following information was provided by the initial reporter: " it has been identified that when opening the package it tears, and doesn't open according to sterile way, leading to risk of contamination to product.".
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