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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/19/2017
Event Type  Injury  
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, as the device was discarded after the event occurred. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
The facility reported difficulty in threading the midline catheter during placement. It was stated that after unsuccessful attempt, it was noted that the catheter was shorter when pulled out of the patient's right arm. X-ray confirmed retained catheter fragment. Surgeon performed successful foreign body retrieval.
 
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Brand Name20 GAUGE POWERGLIDE PRO MIDLINE CATHETER
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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6721625
MDR Text Key80308775
Report Number3006260740-2017-01062
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 06/29/2017,07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberF120100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2017
Distributor Facility Aware Date06/19/2017
Event Location Hospital
Date Report to Manufacturer06/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/18/2017 Patient Sequence Number: 1
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