Device Problem
Leak/Splash (1354)
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Patient Problem
No Code Available (3191)
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Event Date 01/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd insyte autoguard 24g infiltrated and backed out of the vein during use on a pediatric patient.This occurred on 6 separate occasions, but the dates and/or patient information are unknown.This complaint was created to capture the 1 of 2 related incidents.The following information was provided by the initial reporter: "on (b)(6) 2020, the customer reported 4 infiltrates.On (b)(6) 2020, the customer reported 2 more infiltrates (per cpc).On (b)(6) 2020, the customer reported that there had been 7 infiltrates in actuality." it was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.2 events required faciotomies.The patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.
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Manufacturer Narrative
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H.6.Investigation summary as no physical sample, picture sample, product number, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
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Event Description
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It was reported that the bd insyte autoguard 24g infiltrated and backed out of the vein during use on a pediatric patient.This occurred on 6 separate occasions, but the dates and/or patient information are unknown.This complaint was created to capture the 1 of 2 related incidents.The following information was provided by the initial reporter: "on (b)(6) 2020, the customer reported 4 infiltrates.On (b)(6) 2020, the customer reported 2 more infiltrates (per cpc).On (b)(6) 2020, the customer reported that there had been 7 infiltrates in actuality." it was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.2 events required faciotomies.The patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.
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Search Alerts/Recalls
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