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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Model Number 119216M
Device Problems Burst Container or Vessel (1074); Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); 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 device was not returned.
 
Event Description
It was reported that the foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.
 
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 were found adequate and state the following: ¿recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.
 
Manufacturer Narrative
The reported event was unconfirmed.Visual inspection noted one temperature sensing catheter attached to a cut portion of the inlet tubing was received without the original packaging.No obvious defects were noted.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.Active length of the catheter balloon was measured (0.6560") and found to be within specification (0.60" - 0.90").The catheter measured to be 16 fr.A full device history record was not reviewed due to the reported event being unconfirmed.The instructions for use were found adequate and state the following: ¿recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities." correction: d4, d10, h3, h6, h10.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that the foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.
 
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Brand Name
SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER
Type of Device
TEMPERATURE SENSING FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9190126
MDR Text Key167999808
Report Number1018233-2019-06451
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741046308
UDI-Public(01)00801741046308
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/16/2024
Device Model Number119216M
Device Catalogue Number119216M
Device Lot NumberNGDR4136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Initial Date Manufacturer Received 09/22/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received11/15/2019
11/15/2019
Supplement Dates FDA Received10/17/2019
11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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