Catalog Number 405180 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event is unknown; awareness date has been used for this field.H.3.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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Event Description
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It was reported while using bd® spinal needle 25 g x 3 1/2 in.With quincke bevel foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: quantity affected: 1 bx; serial/lot number: (b)(6); are any samples available for return? yes.Reported issue: perxxx: "we were informed that 3 spinal needles from lot# 3062941 had a metallic substance on the inside of the sterile packaging.
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Event Description
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It was reported while using bd® spinal needle 25 g x 3 1/2 in.With quincke bevel foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: quantity affected: 1 bx.Serial/lot number: (b)(6).Are any samples available for return? yes.Reported issue: perxxx: "we were informed that 3 spinal needles from lot# 3062941 had a metallic substance on the inside of the sterile packaging.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 28-jul-2023: h6: investigation summary: sample and photo received by our quality team for investigation.Through visual evaluation, seventeen (17) sealed blisters with unused needles were received in a plastic bag for material 405180 batch 3062941 from the customer for this investigation.One (1) sample (needle) provided it is observed what could be likely a part of a stylet sealed inside the blister with the needle.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
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Search Alerts/Recalls
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