Model Number 328509 |
Device Problem
Defective Device (2588)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that syringe 0.5ml 31ga 8mm 10 bag 500 wal plunger cap was damaged.The following information was provided by the initial reporter: material no: 328509 batch no: unknown it was reported that one syringe had a plunger cap that looked like it had been chewed by a machine.Verbatim: pharmacist called to report issue on behalf of consumer.Stated one relion syringe looks as if the plunger cap was chewed by a machine.One syringe affected.Stated she has reported previous complaints on behalf of this consumer.Advised that only a mail kit would be sent at this time.
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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: h6: investigation summary: customer returned (1) 1/2cc, 8mm, 31g relion syringe in an open poly bag from lot # 0083446.Customer states that the plunger cap looked like it had been chewed by a machine.The returned syringe was examined and exhibited a crushed plunger cap.A review of the device history record was completed for batch# 0083446.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure.H3 other text : see h10.
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Event Description
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It was reported that syringe 0.5ml 31ga 8mm 10 bag 500 wal plunger cap was damaged.The following information was provided by the initial reporter: material no: 328509 batch no: unknown.It was reported that one syringe had a plunger cap that looked like it had been chewed by a machine.Verbatim: pharmacist called to report issue on behalf of consumer.Stated one relion syringe looks as if the plunger cap was chewed by a machine.One syringe affected.Stated she has reported previous complaints on behalf of this consumer.Advised that only a mail kit would be sent at this time.
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Search Alerts/Recalls
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