Catalog Number 381012 |
Device Problems
Leak/Splash (1354); Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/07/2020 |
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.(b)(4).
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24 ga 0.75 in had a defective catheter adapter and breached sterility.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
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Manufacturer Narrative
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Additional information was received which determined that the sterility was not compromised.The following fields were updated with additional information: b.5.Describe event or problem: it was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported." f.10.Event problem codes: 1354.H.10.Device problem codes: 1354.
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received nine unused insyte autoguard bc 24ga units in sealed packaging and one used 24ga catheter/adapter assembly from material number (b)(4), lot number 0016718.The used catheter/adapter assembly was attached to an extension set.In addition, four photographs were submitted which displayed 24ga catheter/adapter assembly attached to an extension set.A closeup view displayed the wire through the middle of the adapter body.A visual/microscopic evaluation was performed on the nine unused units.There was no physical/mechanical damage to the any needle hub or the body of the catheter/adapter assembly.A visual/microscopic evaluation was then performed on the opened catheter/adapter assembly, which displayed a wire/metal coming through the body of the adapter near the pushed tab.The reported issue was confirmed as the adapter(hub) / connector was found defective/damaged.This was physical/mechanical evidence to confirm and support a probable manufacturing process related issue for the reported defect relating to a bent swage pin that had not been detected by the automated pin damage inspection.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
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Search Alerts/Recalls
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