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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD DIFFUSICS PERIPHERAL CATHETER

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BD BD DIFFUSICS PERIPHERAL CATHETER Back to Search Results
Model Number UNAVAILABLE
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2016
Event Type  malfunction  
Event Description
Pt had a peripheral catheter that was inserted to right antecubital as a saline lock. Noted the tip of the saline locked catheter broke off right below the clamp and noted laying in the bed. The iv catheter was intact upon assessment by the rn. Possible catheter/equipment malfunction because the catheter should not have broken off from a saline locked tubing. No harm to pt.
 
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Brand NameBD DIFFUSICS PERIPHERAL CATHETER
Type of DeviceBD DIFFUSICS PERIPHERAL CATHETER
Manufacturer (Section D)
BD
franklin lake NJ 07417
MDR Report Key6099100
MDR Text Key59900458
Report NumberMW5065983
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNAVAILABLE
Device Lot NumberUNAVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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