Catalog Number 408381 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the packaging on the spinal needle 27ga 3-1/2in was difficult to open before use and tore, leaving paper shards in the needle's sterile field.The following information was provided by the initial reporter, translated from (b)(6) to english: "we are still facing difficulty to open the spinal needle.Batch: 9115649.Additional information: the difficult to open the package was noticed before the use.There was no damage to patient/health professional.".
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Manufacturer Narrative
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H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the defect for evaluation.A review of the device history record was performed for the reported lot, 9115649, and no quality issues were found during production.Our quality engineer reviewed the provided photo and determined that the packaging was torn.Based off the provided photo the engineer was able to verify the reported issue.However, without a physical sample available for investigation a definitive root cause could not be determined.
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Event Description
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It was reported that the packaging on the spinal needle 27ga 3-1/2in was difficult to open before use and tore, leaving paper shards in the needle's sterile field.The following information was provided by the initial reporter, translated from portuguese to english: "we are still facing difficulty to open the spinal needle.Batch: 9115649.Additional information: the difficult to open the package was noticed before the use.There was no damage to patient/health professional.".
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Search Alerts/Recalls
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