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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL INTRAVASCULAR CATHETER Back to Search Results
Model Number F120081
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of rebr1673 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (rebr1673) have been reported from the same facility.
 
Event Description
Per sales rep, the facility reported the powerglide pro catheters have been kinking at the hub and do not last 29 days. This file addresses the second device. (b)(6) 2017 - facility reported to the tm that they are using the statlock provided in the kit to secure the catheter.
 
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Brand NameDOT PG PRO 20G 8CM FULL
Type of DeviceINTRAVASCULAR CATHETER
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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key6902846
MDR Text Key87881169
Report Number3006260740-2017-01741
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF120081
Device Catalogue NumberF120081
Device Lot NumberREBR1673
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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