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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 10CM INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 10CM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number M120100
Device Problems Material Frayed (1262); Uncoiled (1659); Physical Resistance (2578)
Patient Problem No Patient Involvement (2645)
Event Date 04/07/2016
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, at this time, for evaluation. A lot history review (lhr) of rezi0872 showed no other similar product complaint(s) from this lot number.
 
Event Description
On 4/19/16 - complainant reported that a the wire from a 20g x 10cm midline catheter frayed. They stated that the wire seemed to uncoil and then fray. The physician did not pull the wire back into the needle because once he felt resistance, he did not go any farther. The patient was not harmed or injured.
 
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Brand NamePOWERGLIDE MIDLINE CATHETER, 20G 10CM
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
maren treft
605 n. 5600 w.
salt lake city, UT 84116
8015225964
MDR Report Key5648812
MDR Text Key45507018
Report Number3006260740-2016-00219
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberM120100
Device Lot NumberREZI0872
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 Manufactured09/01/2015
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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