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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¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383336
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 after performing venipuncture, the safety device on a bd saf-t-intima¿ iv catheter safety system would not activate when withdrawing the needle. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: without sample received to perform an investigation, we cannot confirm or associate the reported defect to manufacturing process. Two pictures received do not show the product or reported defect. This reported defect is not common in our process; however, a possible cause could be the use incorrect of this device after venipuncture. Investigation conclusion: we could not find the exact root cause of the issue. No sample or photo was returned for evaluation.
 
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Brand NameBD SAF-T-INTIMA¿ CLOSED IV CATHETER 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
MDR Report Key7311577
MDR Text Key101636515
Report Number9610847-2018-00036
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
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Catalogue Number383336
Device Lot Number7004943
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/02/2018 Patient Sequence Number: 1
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