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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 20G, 10CM
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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 20G, 10CM Back to Search Results
Catalog Number M020101
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
(b)(6) 2014 - it was reported the catheter allegedly broke during inside the patient during insertion procedure.Reportedly, the catheter piece was retrieved from patient.
 
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reyf1262 showed no other similar product complaint(s) from these lot numbers.
 
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Brand Name
POWERGLIDE MIDLINE CATHETER 20G, 10CM
Manufacturer (Section D)
BARD ACCESS SYSTEMS
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
8015224969
MDR Report Key4385570
MDR Text Key5266848
Report Number3006260740-2014-00629
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM020101
Device Lot NumberREYF1262
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/29/2014
Is the Reporter a Health Professional? No
Event Location Hospital
Initial Date Manufacturer Received 12/08/2014
Initial Date FDA Received12/29/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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