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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOME DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP
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EDWARDS LIFESCIENCES DR CUSTOME DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number VP13B6TSPL
Device Problems Detachment Of Device Component (1104); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2014
Event Type  malfunction  
Event Description
It was reported that the rotate male connector for the pediatric and bd insyte autoguard catheter could not be connected well and got detached during use.There were no patient complications reported.
 
Manufacturer Narrative
The product was not returned for evaluation.The complaint could not be confirmed without the return of the actual complaint unit.
 
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Brand Name
CUSTOME DEFINED PRODUCT
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
carretera sanchez, km 18 1/2
parque ind. de itabo,
haina. san cristobal
DR 
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
carretera sanchez, km 18 1/2
parque ind. de itabo,
haina. san cristobal
DR  
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key3884148
MDR Text Key4425790
Report Number2015691-2014-01409
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVP13B6TSPL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received06/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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