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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of recr2561 showed no other similar product complaint(s) from this lot number. Device not received.
 
Event Description
It was reported that the device was used under ultrasound, proper placement confirmed. It was stated that retraction of needle and extension of guidewire was per protocol. Upon catheter guiding over wire there was reported resistance and ¿unable to cath over wire¿. Device was carefully removed from patient with resistance, it was noted the wire was bent and catheter was torn. It was stated that nothing broke off in patient, but the patient complained of pain with removal and had a large bruise following.
 
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Brand NamePOWERGLIDE PRO MIDLINE CATHETER (20G) (8CM)
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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
heather murphy
605 n. 5600 w.
salt lake city, UT 84116
8015225738
MDR Report Key8002393
MDR Text Key124977527
Report Number3006260740-2018-03028
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF120080T
Device Lot NumberRECR2561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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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