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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. 24 G X 0.75 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. 24 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383319
Device Problem Detachment Of Device Component (1104)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). Results: a sample is not available for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5350830. A manufacturing review indicated that there was no equipment, instrument, process, and/or surfaces that could cause this kind of damage. 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. (b)(4).
 
Event Description
It was reported that a healthcare worker obtained a contaminated needle stick injury from a 24 g x 0. 75 in. Bd saf-t-intima¿ iv catheter safety system. He/she suffered the injury after activating the safety mechanism and the needle came out. It is unknown if the healthcare worker received any medical intervention as the reporting facility felt that this information was confidential and declined to provide it.
 
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Brand Name24 G X 0.75 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 Key6062177
MDR Text Key58602325
Report Number9610847-2016-000036
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number383319
Device Lot Number5350830
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2016
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: 10/27/2016 Patient Sequence Number: 1
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