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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of refs1506 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "accucath ace wire knotted up during insertion, was difficult to remove from patient. " no other information was provided.
 
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Brand NameACCUCATH, ACE 20GX2.25
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12839875
MDR Text Key281028958
Report Number3006260740-2021-04942
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC1202250
Device Lot NumberREFS1506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2021
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: 11/18/2021 Patient Sequence Number: 1
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