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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2022
Event Type  malfunction  
Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event. The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of refw1506 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported " lot refw1506 rn very skilled at usgpiv insertion. Tracked needle tip into vessel lumen and was not able to advance guidewire. Aborted insertion and a different vad was used for access. Upon examination, wire is not coiled properly. Rn stated that she did not examine wire prior to insertion attempt.
 
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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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14584573
MDR Text Key293250808
Report Number3006260740-2022-02081
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741137952
UDI-Public(01)00801741137952
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
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
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 NumberREFW1506
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/02/2022 Patient Sequence Number: 1
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