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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARD 2 WAY MALE 10CC SILICONE ELASTOMER COATED FOLEY CATHETER, 14 FR.; SILICONE ELASTOMER CATHETER
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BARD SDN. BHD. -8040607 BARD 2 WAY MALE 10CC SILICONE ELASTOMER COATED FOLEY CATHETER, 14 FR.; SILICONE ELASTOMER CATHETER Back to Search Results
Catalog Number D165714
Device Problems Detachment Of Device Component (1104); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the catheter expelled itself from the patient in the middle of the night.The patient woke up to find that the catheter had completely come out; however, the patient had no bleeding or pain.The balloon allegedly had a tear in it.The catheter was in situ for 11 weeks.The catheter was not replaced for other unknown reasons.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the catheter expelled itself from the patient in the middle of the night.The patient woke up to find that the catheter had completely come out; however, the patient had no bleeding or pain.The balloon allegedly had a tear in it.The catheter was in situ for 11 weeks.The catheter was not replaced for other unknown reasons.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "do not use ointments or lubricants having a petrolatum base.They will damage latex".(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the catheter expelled itself from the patient in the middle of the night.The patient woke up to find that the catheter had completely come out; however, the patient had no bleeding or pain.The balloon allegedly had a tear in it.The catheter was in situ for 11 weeks.The catheter was not replaced for other unknown reasons.
 
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Brand Name
BARD 2 WAY MALE 10CC SILICONE ELASTOMER COATED FOLEY CATHETER, 14 FR.
Type of Device
SILICONE ELASTOMER CATHETER
Manufacturer (Section D)
BARD SDN. BHD. -8040607
kulim industrial estate
lot 57c
kulim, kedah 09000
MY  09000
Manufacturer (Section G)
BARD SDN. BHD. -8040607
kulim industrial estate
lot 57c
kulim, kedah 09000
MY   09000
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6245281
MDR Text Key65069442
Report Number1018233-2017-00077
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD165714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2017
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 Sequence Number1
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