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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 6F120080
Device Problems Crack (1135); Defective Component (2292); Difficult to Advance (2920)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of reeq2531 showed two other similar product complaint(s) from this lot number. The complaints for this lot number have been reported from the same facility in (b)(6).
 
Event Description
It was reported that when inserted to the patient it did not go in smoothly so the wire was checked with ultrasound and removed because the catheter tip was noted to be cracked. It was reported this occurred with three devices this report addresses the second device.
 
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Brand Name20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
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 Key11380635
MDR Text Key234942502
Report Number3006260740-2021-00495
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6F120080
Device Lot NumberREEQ2531
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2020
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: 02/25/2021 Patient Sequence Number: 1
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