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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD REYNOSA S.A. DE C.V. -9617592 POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported that the introducer was not strong and mushroomed back/bent causing a need to nick skin of the patient.
 
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Brand Name
POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX 
MDR Report Key9880111
Report Number3006260740-2020-01043
Device Sequence Number16904484
Product Code LJS
UDI-Device Identifier00801741154973
UDI-Public(01)00801741154973
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K053501
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberCK000526B
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2020
Initial Report FDA Received Date03/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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