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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 INTERVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2018
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.
 
Event Description
It was reported that a bd saf-t-intima iv catheter safety system had needle retraction failure. The needle hung loosely and failed to retract after use. There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
A device history report was conducted for lot number 7349714, and no related abnormalities were found. This lot of saf-t-intima w/adapter was manufactured on (b)(6) 2018, and this is the first instance of this complication occurring in this lot. 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. A photograph was provided for the purpose of aiding our quality engineer's investigation, however the photograph was unable to provide any insights into the issue reported by your facility. Bd engineers reviewed the manufacturing process and the associated procedures, but were unable to associate this issue with the manufacturing process. No corrective action was performed since this issue could not be confirmed as manufacturing related. Bd will continue to track and trend for this issue.
 
Event Description
It was reported that a bd saf-t-intima iv catheter safety system had needle retraction failure. The needle hung loosely and failed to retract after use. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key7852081
MDR Text Key119535600
Report Number9610847-2018-00294
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 other,user facility
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Catalogue Number383313
Device Lot Number7349714
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/06/2018 Patient Sequence Number: 1
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