Catalog Number 401383 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 04/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that a anesthesia tray basic spinal had a damaged plunger rod.The following information was provided by the initial reporter: "on (b)(6) 2020, physician (b)(6), suffered an accident with a needle for insulin, after the 3ml syringe's plumber (from spinal anesthesia kit), used to perform the anesthetic button, bent and slipped from her hand, causing a perforation.Material injured the physician that was performing the procedure, material # 401383".
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Event Description
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It was reported that a anesthesia tray basic spinal had a damaged plunger rod.The following information was provided by the initial reporter: "on (b)(6) 2020, physician (b)(6), suffered an accident with a needle for insulin, after the 3ml syringe's plumber (from spinal anesthesia kit), used to perform the anesthetic button, bent and slipped from her hand, causing a perforation.Material injured the physician that was performing the procedure, material#: 401383".
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Manufacturer Narrative
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H.6.Investigation summary: 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 could not be performed as the lot was unknown.Our quality engineer reviewed the provided photo and observed that the 3ml plunger was damaged.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.
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Search Alerts/Recalls
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