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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 ACCUCATH 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0202250
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of unable to retract guidewire is confirmed but the exact cause remains unknown. Three photo samples of an accucath device were provided for evaluation. The first photo shows the catheter with the guidewire present internally. The catheter is wrinkled and damaged forming a ¿j¿ shape. The coiled guidewire tip appears to be bending against the catheter tip. The second image shows the entire device. The catheter is still present near the housing and the needle appears to have been retracted. The third image shows the product label which indicates lot: reey2674. Based on the photo sample provided, possible contributing factors include kinking or deformation of the guidewire during insertion. The guidewire appears to have deformed around the catheter contributing to the interference during retraction. Since the reported issue was observed in the images provided, the complaint is confirmed but the exact cause remains unknown. A lot history review (lhr) of reey2674 showed one other similar product complaint(s) from this lot number.
 
Event Description
It was reported the guidewire would not retract. No other information was provided. 6/10/2021: the returned device was found kinked.
 
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Brand NameACCUCATH 20 GX2.25
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
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12093703
MDR Text Key259267601
Report Number3006260740-2021-02489
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREEY2674
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
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: 06/30/2021 Patient Sequence Number: 1
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