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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. 20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383336
Device Problems Break (1069); Detachment Of Device Component (1104); Shielding Failure (1568)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2016
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
There were two specific issues reported associated with a 20 g x 1 in. Bd saf-t-intima iv catheter safety system. The guide wire broke off during removal after successful iv insertion (occurred in 22 and 20 gauge iv catheters). Staff report that when removing the trocar, it doesn't sheath into the protective sleeve, leaving sharps exposed. Specific details regarding the number of incidents of each issue and which iv catheter was used in each incident were not provided and the initial reporter only provided catalog and lot information for the 20 gauge device. No injury or medical intervention was reported.
 
Manufacturer Narrative
Results: a sample was not returned for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6060507. A manufacturing review revealed that no equipment, instrument, process, or surfaces could cause the type of damage reported. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Manufacturer Narrative
On (b)(6) 2017, an email from bd personnel was received reporting the product complaint (originally reported on the initial mdr on (b)(6) 2016). The email chain shows the original complaint was submitted to the bd privacy department on (b)(6) 2016, however, this information was not sent to the bd regional complaint center until (b)(6) 2017. Therefore the bd notification date has been changed from (b)(6) 2016. Date received by manufacturer: 6/22/2017.
 
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Brand Name20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6080715
MDR Text Key59562826
Report Number9610847-2016-00035
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number383336
Device Lot Number6060507
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/04/2016 Patient Sequence Number: 1
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