Catalog Number 381033 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
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 that iag bc pro global pnk 20ga x 1.0in was not able to connect.The following information was provided by the initial reporter: on the (b)(6) 2021, in the hospital carried out a material vigilance on the 20g catheter."catheter set up for an injected scan.When connecting the catheter to the infusion tubing, impossible to connect the catheter to the tubing.After testing, no problem with the tubing, it is the luer tip of the catheter that causes the problem.Need to change the catheter and therefore put the patient back on.
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Event Description
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It was reported that iag bc pro global pnk 20ga x 1.0in was not able to connect.The following information was provided by the initial reporter: on the (b)(6) 2021, in the hospital carried out a material vigilance on the 20g catheter."catheter set up for an injected scan.When connecting the catheter to the infusion tubing, impossible to connect the catheter to the tubing.After testing, no problem with the tubing, it is the luer tip of the catheter that causes the problem.Need to change the catheter and therefore put the patient back on.
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Manufacturer Narrative
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H.6.Investigation: bd received two 20 gauge insyte autoguard blood control units from lot 0132442 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed damage to the inner wall near the end of the adapter of the first unit.Next, a water/air leak test was performed on the unit and leakage was observed at the luer connection.Next, the second unit was inspected and no physical/mechanical damage was found to the unit.A water/air leak test was performed for this unit as well and no leakage was observed coming from the device.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that the damage to the inner wall was a manufacturing defect.
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Search Alerts/Recalls
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