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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE 20GX8CM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE 20GX8CM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F120080T
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
The information provided by bd 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 bd. The manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of reep4157 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via medwatch "midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with the wire advancement, the catheter was removed. Upon inspection of the catheter, the 2cm tip of the poly catheter was missing. Repeat elbow x-ray taken on (b)(6)2020 and a foreign body noted in the same place. ".
 
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Brand NamePOWERGLIDE PRO MIDLINE 20GX8CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10788539
MDR Text Key214721455
Report Number3006260740-2020-20387
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,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberF120080T
Device Catalogue NumberF120080T
Device Lot NumberREEP4157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2020
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: 11/04/2020 Patient Sequence Number: 1
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