Model Number 328438 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2021 |
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.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 that a syringe 0.3ml 31g 8mm wholeunit 10bg 500 separated from the hub and was damaged before use.The following was reported by the initial reporter: "it was reported that needle shield could not be removed from some syringes.One needle shield was smashed and the needle hub separated when removing the needle shield.Verbatim: pet owner reported, she could not remove needle shield from some syringes stated, the needle shield was "smashed" on one syringe stated, needle hub separated, when removing needle shield".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/30/2021.H.6.Investigation: customer returned five syringes and a loose needle shield.The returned pouch indicates they are 0.3ml, 31 gauge, 8mm syringes from lot 0153971.Two of the syringes had their needle shield and hub separated from the barrel.The hubs had become lodged inside the shields.There is no damage to either the connectors at the distal tip of the barrels or their respective needle hubs.No signs of use and no other defects found.The remaining three syringes were returned fully intact.A needle shield pull force test was performed on each of these syringes.The needle shields required 4.08 lbs, 4.91 lbs, and 5.35 lbs of force to be removed.Removing the needle shields found that the hub was properly attached to the barrel of the syringe.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.With the needle hub attached and the needle shield being within pull force specification, the report of the hub separating from the barrels could not be confirmed for these samples.The loose needle shield was returned damaged.The shield of the syringe is crushed and slightly warped towards the middle of the length of the shield.The damage has resulted in it splitting open at one location.If a tool was used to pry the needle shield from the barrel, it may have exerted enough force to damage the shield in this manner.A review of the device history record was completed for batch # 0153971 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted for out of spec shield pull.There was one (1) notification noted that did not pertain to the complaint.Capa#1630423 was initiated.H3 other text : see h.10.
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Event Description
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It was reported that a syringe 0.3ml 31g 8mm wholeunit 10bg 500 separated from the hub and was damaged before use.The following was reported by the initial reporter: "it was reported that needle shield could not be removed from some syringes.One needle shield was smashed and the needle hub separated when removing the needle shield.Verbatim: pet owner reported, she could not remove needle shield from some syringes stated, the needle shield was "smashed" on one syringe stated, needle hub separated, when removing needle shield".
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Search Alerts/Recalls
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