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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; N/A
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; N/A Back to Search Results
Catalog Number 383319
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).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 bd saf-t-intima¿ iv catheter safety system broke.This was discovered during use.The following information was provided by the initial reporter: after placing the device and removing the needle it was noticed that there was blood and liquid leakage.The device has been removed and they noticed a missing part with the catheter broken.The patient (children) has been tested with x-ray but the result was negative.
 
Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 9210990 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one picture sample was received for evaluation by our quality engineer team.Through examination of the picture, the catheter was observed broken.The quality engineer team attempted to reproduce the observed defect through functionally testing the same catheter material within the manufacturing facility; however, the defect could not be replicated.It is suspected that something extraordinary occurred during the activation of the device, which resulted in the damaged catheter.At this time, an exact cause for this incident could not be determined.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.
 
Event Description
It was reported that bd saf-t-intima¿ iv catheter safety system broke.This was discovered during use.The following information was provided by the initial reporter: after placing the device and removing the needle it was noticed that there was blood and liquid leakage.The device has been removed and they noticed a missing part with the catheter broken.The patient (children) has been tested with x-ray but the result was negative.
 
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Brand Name
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of Device
N/A
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9955861
MDR Text Key187511744
Report Number9610847-2020-00128
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
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 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number383319
Device Lot Number9210990
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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