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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Thrombus (2101)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redr1720 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (redr1720) have been reported from the same facility.
 
Event or Problem Description
It was reported the picc was placed on (b)(6) 2020 and patient developed a dvt.No other information was provided.
 
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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 Key9983140
Report Number3006260740-2020-01454
Device Sequence Number3070716
Product Code LJS
UDI-Device Identifier00801741134166
UDI-Public(01)00801741134166
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K162443
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue NumberS1274108PD
Device Lot NumberREDR1720
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/30/2020
Initial Report FDA Received Date04/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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