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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TPS STYLET 6F BASIC TRAY WITH MICROINTRODUC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TPS STYLET 6F BASIC TRAY WITH MICROINTRODUC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/29/2020
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 catheter (of power picc for power injection, which was placed in the patient) was unable to bear the pressure and damaged so that the contrast medium leaked out as the unconfined route of triple lumen catheter was used to infuse contrast medium on ct thoracoabdominal imaging for the patient of traumatic arterial injury.There was no reported patient injury.
 
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Brand Name
POWERPICC CATHETER WITH SHERLOCK 3CG TPS STYLET 6F BASIC TRAY WITH MICROINTRODUC
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 Key10313762
Report Number3006260740-2020-02610
Device Sequence Number10993692
Product Code LJS
UDI-Device Identifier00801741034701
UDI-Public(01)00801741034701
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K091324
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/23/2020
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 Number1386118
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2020
Initial Report FDA Received Date07/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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