Model Number 328509 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2023 |
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.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2269258.D4.Medical device expiration date: 31-oct-2027.H4.Device manufacture date: 26-sep-2022.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 relion insulin syringes foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: spouse called on behalf of spouse.Stated, when he pushed down on plunger rod prior to injection, "liquid" came out.Stated his spouse did not use syringes with "liquid" found inside the barrel.Stated, some needles are dull.
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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: 08may2023.H6: investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.(b)(4) was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.
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Event Description
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It was reported while using relion insulin syringes foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: spouse called on behalf of spouse.Stated, when he pushed down on plunger rod prior to injection, "liquid" came out stated his spouse did not use syringes with "liquid" found inside the barrel stated, some needles are dull.
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Search Alerts/Recalls
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