Catalog Number 381437 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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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: 07-dec-2022.H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one used 20g x 1.88in.Insyte autoguard unit from lot number 1300906.A gross visual inspection of the returned unit found that the needle was in the un-retracted position and the button had not been depressed.The catheter assembly was not returned.Further microscopic inspection found adhesive between the needle hub and grip which prevented needle retraction.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the adhesive dispensing station.This may occur at the adhesive dispense process due to station misalignment, part misalignment or adhesive buildup on the nozzle.Per our quality control plan, inspections for needle retraction and excessive adhesive are performed periodically during the manufacturing process to mitigate the occurrence of this defect.Preventative maintenance (pm¿s) is performed to maintain and ensure proper functioning of equipment.Pm records were verified to be up to date during the production of this lot.In addition, a device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".
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Search Alerts/Recalls
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