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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT PICC WITH SHERLOCK 5F DUAL-LUMEN REVERSE TAPER PICC WITH TIP LOCATI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS GROSHONG NXT PICC WITH SHERLOCK 5F DUAL-LUMEN REVERSE TAPER PICC WITH TIP LOCATI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 9857505
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Reaction (2414)
Date of Event 10/29/2013
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 rewl0810 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
 
Event or Problem Description
It was reported that patient had an adverse reaction when picc was inserted.Symptoms passed after a few minutes.No other information was provided.
 
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Brand Name
GROSHONG NXT PICC WITH SHERLOCK 5F DUAL-LUMEN REVERSE TAPER PICC WITH TIP LOCATI
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 Key9453559
Report Number3006260740-2019-03819
Device Sequence Number19348058
Product Code LJS
UDI-Device Identifier00801741036163
UDI-Public(01)00801741036163
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K063240
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/11/2019
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 Catalogue Number9857505
Device Lot NumberREWL0810
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/11/2019
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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