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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Defective Component (2292)
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, as the device was discarded after the event occurred.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 galt microintroducers in the provena kits are peeling up, creating a lip when inserting.No patient harm reported.
 
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Brand Name
DOT PROV SP 4F DL MAX
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9428470
Report Number3006260740-2019-03792
Device Sequence Number16571818
Product Code LJS
UDI-Device Identifier00801741134166
UDI-Public(01)00801741134166
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K162443
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/06/2019
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 NumberS1274108PD
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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