Catalog Number 381123 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
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 angiocath bl 22ga x 1.0in had air in the line.The following information was provided by the initial reporter: this is a report about air in line with the use of angiocath.According to the customer's report, when connecting to the a line, air entered.The customer is suspecting that there may be a crack on the catheter or the catheter hub.
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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: 2021-10-25 h6: investigation summary bd received a 22 gauge angiocath device from lot 9329998 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 unit and observed no visual damage to the unit.Next, the unit was sent for a ct scan to identify if there were any micro-cracks that could not be identified.The ct scan confirmed that there was no damage to the sample that could have contributed to a possible leak or entryway for air.Based off of the visual inspection and ct scan the engineer could not verify the reported claim.Since no defects were found during inspection a definitive root cause could not be determined.H3 other text : see h10.
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Event Description
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It was reported that angiocath bl 22ga x 1.0in had air in the line.The following information was provided by the initial reporter: this is a report about air in line with the use of angiocath.According to the customer's report, when connecting to the a line, air entered.The customer is suspecting that there may be a crack on the catheter or the catheter hub.
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Search Alerts/Recalls
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