Model Number 305271 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 integra¿ 3 ml retracting safety syringe with 23 g x 1 in.The syringe did not retract.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: 2 sterile sealed packages and complained about the needles attached to the integra syringes where not retracting.
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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: 29-nov-2022.H6: investigation summary : it was reported the needles are not retracting as intended.To aid in the investigation, two 3ml 23x1 syringes in sealed packaging blisters from lot 9001858 were received for evaluation by our quality team.Each sample was functionally tested.The reported defect could not be confirmed based upon the samples received.A device history record review was completed for provided material number 305271, lot number 9001858.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9001858 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.H3 other text : see h10.
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Event Description
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It was reported while using bd integra¿ 3 ml retracting safety syringe with 23 g x 1 in.The syringe did not retract.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: 2 sterile sealed packages and complained about the needles attached to the integra syringes where not retracting.
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Search Alerts/Recalls
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