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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problems Fever (1858); Thrombus (2101)
Event Date 03/13/2020
Event Type  Injury  
Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of redp1982 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 Description

It was reported that this patient had a high fever. Removed the catheter and found fluid leaks at the 29 cm mark of the catheter inserted. No other information was provided.

 
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Brand NameGROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9917303
MDR Text Key186605578
Report Number3006260740-2020-01155
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK871080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number7715405
Device LOT NumberREDP1982
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2020 Patient Sequence Number: 1
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