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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN PHILLIPS FOLLOWER URETHRAL CATHETER 8 FR., STERILE

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C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN PHILLIPS FOLLOWER URETHRAL CATHETER 8 FR., STERILE Back to Search Results
Model Number 021508
Device Problems Expiration Date Error (2528); Inaccurate Information (4051)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the expiration date on the back label of the product did not match with the date on the analytical certificate. Certificate expiration date lot: gfdp1338 ref (b)(4) exp. Date. 31-mar-2024. Label expiration date lot: gfdp1338 ref (b)(4) exp. Date. Apr-2024. It was also stated that the label to the customer was referred in spanish. According to the quality team in (b)(6): - this label is applied on the dc in (b)(6), according to the nationalization process based on (b)(6) regulation. - the information of expiration date that goes on this label, comes from sap. However for legacy bard products the information inserted in sap is done manually. - the analytical certificate comes from the manufacturing plant.
 
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Brand NameBARD WOVEN PHILLIPS FOLLOWER URETHRAL CATHETER 8 FR., STERILE
Type of DeviceCATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10511084
MDR Text Key207719830
Report Number1018233-2020-05780
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number021508
Device Catalogue Number021508
Device Lot NumberGFDP1338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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