Catalog Number 305270 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd integra syringe had a needle retraction failure.The following information was provided by the initial reporter: "im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the the needle tip flew off while retracting the syringe.This is the second needle same lot number at our facility that this happened with." verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2023.Type of incident/problem: malfunction - during or after use.Level of harm: no apparent harm - reached patient/person.Ahs optional report to cmdsnet (health canada): yes.Incident details: im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the needle tip flew off while retracting the syringe.This is the second needle same lot number at our facility that this happened with.Manufacturer code/model: 305270.Serial or lot number: (b)(6).Expiry date: 2026-09-30.
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Manufacturer Narrative
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One photo of a 25x1" integra needle was received for evaluated.The image shows a loose needle on the floor with the cannula attached to the hub.The reported defect cannot be confirmed from the photo provided.The condition observed is acceptable per product specification.It is recommended to hand-tighten the needle to the syringe prior to use.The reported defect was not identified in the samples received.Therefore, no corrective action is required currently.Lot 1302455 is considered in compliance with our product specification requirements.It is recommended to hand-tighten the needle to the syringe prior to use.A device history record review was completed for provided lot number 1302455 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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Material#: 305270, lot#: 1302455.It was reported by the customer that the after administration the needle tip flew off while retracting the syringe.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(6).Date of incident (yyyy-mm-dd): 2023-12-17.Type of incident/problem: malfunction - during or after use level of harm: no apparent harm - reached patient/person ahs optional report to cmdsnet (health canada): yes.Incident details: im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the needle tip flew off while retracting the syringe.This is the second needle same lot number at our.Facility that this happened with.Manufacturer code/model: 305270 serial or lot number: 1302455.Expiry date: 2026-09-30.
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Search Alerts/Recalls
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