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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 INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383323
Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
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 that bd saf-t-intima¿ iv catheter safety system had the following issue,"the safety mechanism failed and exposed the needle made contact with the tech face". No serious injury or medical intervention reported.
 
Event Description
It was reported that bd saf-t-intima iv catheter safety system had the following issue,"the safety mechanism failed and exposed the needle made contact with the tech face". No serious injury or medical intervention reported.
 
Manufacturer Narrative
The device history report for lot number 6277683 was reviewed, no related abnormalities were found. Material number (b)(4) for lot 6277683 was manufactured on 10/12/2016. This is the first instance of this failure mode with this lot number. According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections. Additionally representative samples were provided for the purpose of aiding our quality engineer's investigation, all available units were subjected to pull testing and found to be within product specification. Without the ability to observe or duplicate the reported issue our investigators were unable to determine the root cause for this complaint. The reported safety shield activation failure by customer was not confirmed after evaluate the representative samples received. 6 representative samples met the acceptance criteria according si-16sp. No values out of specification, problems during activation or exposed cannula were found. This reported defect could be related with an incorrect activation device by the user; since, instruction sheet d12556 (figure 3 and 4), show correct way to perform this activation. Always refer to ifu for product usage recommendations. We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary. No corrective action required at the failure. Process (b)(4) was reviewed and there are proper controls in place to detect product malfunctions. Based on investigation results to date, the root cause could be related with lack of training in the use of the product. No corrective action was performed since this issue could not be confirmed as manufacturing related.
 
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Brand NameBD 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 UT 84070
MDR Report Key7652870
MDR Text Key113009812
Report Number9610847-2018-00193
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number383323
Device Lot Number6277683
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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