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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
Model Number 383313
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: bd received 4 representative samples submitted for evaluation. The reported issue was confirmed upon testing of the samples. During internal flow testing, the samples were occluded. Further examination showed that excess medical grade silicone from our lubrication process was found within the cannula. The excess was stuck to the needle, clogging the cannula, resulting in occlusion. A device history record review showed no non-conformances associated with this issue during the production of this batch. A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately. Corrective actions have been initiated and a manufacturing root cause has been identified. Actions have been made to address the issue. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 10 bd saf-t-intima¿ iv catheter safety systems' needles were occluded with excess silicone. The following information was provided by the initial reporter, translated from chinese to english: "the needle couldn't exhaust before puncturing during examination" via bd investigation: "during internal flow testing, the samples were occluded. Further examination showed that excess medical grade silicone from our lubrication process was found within the cannula. The excess was stuck to the needle, clogging the cannula, resulting in occlusion. ".
 
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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
MX
MDR Report Key12586137
MDR Text Key275046532
Report Number9610847-2021-00488
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
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383313
Device Catalogue Number383313
Device Lot Number0351255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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