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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38103414
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use of the bd insyte¿ autoguard¿ bc the device had a hole in it. There was no report of blood exposure or damage to patient. There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation results: device/batch history record review findings: this iv sub-assembly lot (7226519) was built on afa line 9 on 19aug2017 through 21aug2017 and bulk packaged from afa line 9 for the quantity of (b)(4) units. Per review it was noted that there were no rejected findings throughout the build of this lot that would impact upon the quality of the product of the catheters. Set-up and in process samples including (but not limited to) adapter damage/cracked (interior-exterior), damaged component and catheter leak test passed per specification. The peura (end user risk analysis) was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Sap (qn) database review findings: subject code was an s1 severity ranking. Review was conducted for this mdr- level a investigation; as a result of the review there were no reject activity findings relevant to the defect associated with the iv sub-assembly lot number provided for this incident. Observations and testing: although a sample was not returned, a photo was provided for evaluation of this incident. The photo revealed the unit was of a pink 20g blood control adapter which had media present in the adapter. Observed a void in the wall of the adapter. The void was oval-shaped and ran linear with the adapter starting at mid body (adapter) and running towards the threads. Also visible in the photo was a partial view of the grip assembly and fully retracted needle and a miscellaneous injection site which revealed traces of media. Conclusions: confirmation of the failure of needle hub defective / damaged, as stated in the description of the complaint was conclusive based evaluation of the photo provided for this incident. Confirmed the photo provided for this incident displayed evidence of a hole in the adapter. There was no evidence to confirm or support manufacturing process related issues for the defect reported in the product incident report.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7280492
MDR Text Key100556812
Report Number1710034-2018-00047
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2020
Device Catalogue Number38103414
Device Lot Number7332932
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/19/2018 Patient Sequence Number: 1
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