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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD 24G; INTRAVASCULAR CATHETER
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BECTON DICKINSON BD INSYTE AUTOGUARD 24G; INTRAVASCULAR CATHETER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
BD INSYTE AUTOGUARD 24G
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9649278
MDR Text Key178351835
Report Number2243072-2020-00112
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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