• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN STATLOCK DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN STATLOCK DEVICE Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2023
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 after turning patient in bed, patients foley catheter was noted to be out from the foley statlock.When staff was about to reattach the foley balloon port or urine drainage port to the statlock noticed that the balloon port was severed and soon right after the catheter then slipped out of patient¿s penis and balloon was already deflated.Patient was not injured while this incident occurred.Stated that the staff heard in tier 4 this morning that there were also reports of the drainage bag emptying very slowly.This sounds like an air filter problem to them.
 
Manufacturer Narrative
The reported event was inconclusive since sample condition was poor.It is unknown whether the device had met relevant specifications.The product was used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with an inlet tube and sample port connector.Visual inspection of the sample noted the inflation arm/valve cap disconnected from the catheter and the foley statlock could not be evaluated since sample condition was poor, therefore this investigation is considered inconclusive.Flushed the sample port and filled the drainage bag with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no issues were observed from the drainage bag.A potential root cause for this failure mode could be ¿inappropriate snap fit".Based on information in the fmea, the residual risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.The lot number is unknown; therefore, the device history record could not be reviewed.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.
 
Event Description
It was reported that after turning patient in bed, patients foley catheter was noted to be out from the foley statlock.When staff was about to reattach the foley balloon port or urine drainage port to the statlock noticed that the balloon port was severed and soon right after the catheter then slipped out of patient¿s penis and balloon was already deflated.Patient was not injured while this incident occurred.Stated that the staff heard in tier 4 this morning that there were also reports of the drainage bag emptying very slowly.This sounds like an air filter problem to them.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN STATLOCK DEVICE
Type of Device
UNKNOWN STATLOCK DEVICE
Manufacturer (Section D)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16403742
MDR Text Key309892676
Report Number1018233-2023-01003
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/25/2023
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2023
Initial Date FDA Received02/20/2023
Supplement Dates Manufacturer Received04/25/2023
Supplement Dates FDA Received05/03/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-